Sterilization container capable of providing an indication regarding whether or not surgical instruments sterilized in the container were properly sterilized

ABSTRACT

A sterilization container for sterilizing at least one surgical instrument. The container includes at least one sensor for measuring an environmental characteristic of the container during the sterilization of the instrument. The measure of the environmental characteristic is supplied to a processor. The processor compares the measurement of the container environment to a validated measurement for the sterilization process. If the measured environmental characteristic is at least equal to the validated sterilization process measurement, the processor presents an indication that the surgical instruments was properly sterilized.

RELATIONSHIP TO EARLIER FILED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/849,157 filed 9 Sep. 2015. U.S. patent application Ser. No.14/849,157 is a continuation of PCT App. No. PCT/US2014/024799 filed 12Mar. 2014. PCT App. No. PCT/US2014/024799 is a non-provisionalapplication based on U.S. Prov. Pat. App. No. 61/779,956 filed 13 Mar.2013. The contents of the priority applications are incorporated hereinby reference.

FIELD OF THE INVENTION

This invention relates generally to sterilization systems for surgicalinstruments. More particularly, this invention relates to a containerand electronic sensor module for monitoring and verifying appropriatesterilization measurements have been met during a sterilization processand a method for using an electronic sensor module for determining ifsurgical instruments within the container have been properly exposed toa set of required process measurements during a sterilization processcycle.

BACKGROUND OF THE INVENTION

Sterilization of instruments and equipment used in medical and surgicalprocedures is important to prevent post-surgical infections in patients.Hospitals and medical facilities utilize a variety of cleaning andsterilization techniques and methods to re-process soiled or previouslyused surgical instruments. A hospital or medical center typicallyincludes a sterile processing department that handles the cleaning andsterilization of medical instruments of the facility.

The sterile processing department commonly has several sectionsincluding a cleaning section, a sterilization section and a sterilestorage section. Surgical equipment used during medical proceduresreturn from the operating room to the cleaning section. In the cleaningsection, the surgical instruments are cleaned of any visible liquid orsolid medical waste and processed through a manual or an automatedwashing process. The automated washer uses high pressure streams ofwater and detergent to remove debris and residue from instrumentsurfaces. The washer exposes surgical instruments to high temperaturewater and sometimes damaging chemicals for a period of time. Somesurgical instruments are not amenable to processing through theautomated washer and are required to be manually washed.

After washing, the surgical instruments undergo a functional equipmentinspection to check for broken parts or defects in the surgicalequipment. Defective parts are repaired or replaced. Next, theindividual surgical instruments are prepared for sterilization byplacement of the surgical instruments in containers. Some surgicalinstruments are required to have a certain geometrical orientationduring the sterilization process so that sterilant may effectivelyenter, contact and leave the surgical equipment during processing. Theinstruments can be grouped together by procedure to form a surgical toolset.

To preserve the sterility of the surgical instruments during handlingand storage after sterilization, surgical instruments are typicallyplaced into various container systems that form a sterile barrier aroundthe instruments. Given that this barrier is intended to prevent ambientmicrobial organisms from adhering to the sterilized instruments thesebarriers are sometimes referred to as microbial barriers or SBSs(sterile barrier systems). One popular container system in use today isone that is constructed with two types of materials, one material beinga “rigid” impermeable material and the other material that is amicrobial filter. The microbial filter is constructed to allow thesterilizing agent, typically a vapor or gas, to penetrate duringsterilization but prevents microorganisms such as mycobacterium,vegetative bacteria, viruses, fungi, and bacterial spores from enteringthe container. Another container system is formed by using a perforated“rigid” material such as aluminum or stainless steel and the entireperforated container is wrapped with a microbial filter like material.The perforated “rigid” material provides structure to transport, handleand stack the containers of surgical instruments, but by itself does notprevent micro-organisms from entering the container. The sterile barriermaterial protects the surgical instruments from contamination duringpost sterilization handling and storage. The outer sterile wrap can be aspun polypropylene wrap and is permeable to sterilizing fluids or gaseswhile forming a microbial barrier. When a container system is not used,individual surgical instruments can be packed in a flexible envelopematerial such as Tyvek typically constructed of a semi-permeable Tyvekon one side to allow the sterilizing agent to ingress and egress, and anon-permeable Mylar on the other side that allows the contents to beviewed

To visually verify that containers of surgical instruments have beenexposed to sterilizing agents, chemical indicators may be added to theinside and/or the outside of the sterile barrier system prior toundergoing the sterilization process. Chemical indicators arespecifically designed for the type of sterilizing agent, gas or vaporused. The Class I Chemical Indicator is a chemical indicator systemrecognized by the FDA and JCAHO for use in hospitals in the UnitedStates. European regulatory agencies currently recognize proof ofexposure chemical indicators, which provide parametric release, as wellas Class I chemical indicators. A Class I chemical indicator provides avisual indication that it has been exposed to a sterilization agent, butdoes not indicate the level of exposure or amount of time of exposure.External chemical indicators are typically used so the hospital sterileprocessing department personnel can determine where the individualcontainers of equipment are in the workflow within the department andthe internal chemical indicators are used to indicate to the hospitalpersonnel setting up for a surgical procedure that the equipment insideof the sterile barrier has been exposed to a sterilization agent. If theexternal chemical indicator does not indicate exposure to thesterilization agent within the Sterile Processing Department, thesurgical tool set must be processed to insure sterility. If the internalchemical indicator does not indicate exposure to the sterilization agentwhen the container is opened, the container and equipment must bereturned to the Sterile Processing Department for reprocessing,typically beginning with the cleaning process. Determining that acontainer of surgical equipment has not been exposed to a sterilizingagent, while preparing for a surgical procedure is disruptive to theefficiency of the operating room and requires that another set ofsurgical equipment be located and properly set ultimately causingschedule delays and/or other adverse disruptions. Various types ofchemical indicators have been developed including tapes, paper stripsand catalytically activated systems. Tapes, labels, and paper strips areprinted with an ink that changes color when exposed to a specificsterilization agent or chemical. Integrating or wicking paper is madewith an ink or chemical at one end that melts and wicks along the paperover time under the desired process values. A color bar reaches anacceptable area if the process values are met. The chemical indicatorsare different for the various types of sterilization modalities, andthus the chemical indicator visual changes are not the same acrosssterilization methods. Sometimes the color change indicating exposure toone modality, e.g. steam autoclave, is opposite the color change for adifferent sterilizing modality, e.g. hydrogen peroxide sterilization.This causes confusion for the health care workers when reading andinterpreting the various chemical indicator color changes.

Once the surgical instruments are fully packed and ready forsterilization, the surgical tool sets are processed through asterilization process to destroy microorganisms. Various sterilizationmethods and agents have been used to sterilize surgical instruments.

Saturated Steam heat is one sterilant that is used to destroymicroorganisms. Pressures higher than atmospheric pressure are necessaryto increase the temperature of the steam for destruction ofmicroorganisms that pose a greater challenge to kill. The saturatedsteam at a required temperature and time must penetrate and reach everysurface of the items to be sterilized. A sterilization chamber containsthe articles to be sterilized. When steam initially enters thesterilizer chamber under pressure, it condenses upon contact with colditems. This condensation liberates heat, simultaneously heating andwetting items in the load. The entire load must be exposed to moist heatfor a minimum time and at a minimum defined temperature in order toaffect sterilization. For example, one type of surgical tool set mayrequire 34 minutes at 270 degrees Fahrenheit to destroy themicro-organisms and another 20 minutes of evacuation to dry theinstruments within the sterile barrier so that condensation does notaccumulate within the sterile barrier. A minimum temperature-time andsteam concentration relationship is required to be maintained throughoutall portions within the sterile barrier and across the sterilizerchamber load to complete sterilization. The time, temperature and steamconcentration to destroy micro-organisms depends upon many factors. Forexample the size, surface area, thermal mass, orientations and depths ofinternal cavities of the contents of the load within the sterile barrieras well as the steam penetration properties of the sterile barrier usedcan affect the reliability to destroy micro-organisms. After the steamcycle has been completed, the water condensate must be evaporated to drycontents of the load to maintain sterility. A vacuum can be drawn on thechamber to assist in the evaporation of any remaining water. Thenormative reference commonly used to determine appropriate sterilizationexposure times are listed in Table 5 which is taken directly fromANSI/AAMI ST79: 2010/A2: 2011 “Comprehensive Guide to SteamSterilization and Sterility Assurance in Health Care Facilities,Amendment 2”.

TABLE 5 Minimum cycle times for dynamic-air removal steam sterilizationcycles Exposure Exposure time at time at 132° C. 135° C. Item (270° F.)(275° F.) Drying times Wrapped instruments 4 minutes 20 to 30 minutes 3minutes 16 minutes Textile packs 4 minutes  5 to 20 minutes 3 minutes  3minutes Wrapped utensils 4 minutes 20 minutes 3 minutes 16 minutesUnwrapped nonporous 3 minutes 3 minutes NA items (e.g., instruments)Unwrapped nonporous 4 minutes 3 minutes NA and porous items in mixedload NOTE— This table represents the variation in sterilizermanufacturers' recommendations for exposure at different temperatures.For a specific sterilizer, consult only that manufacturer'srecommendations.

Some surgical equipment such as gastroscopes and endoscopes aresensitive to the steam and high temperatures required by steamsterilization. Hydrogen peroxide vapor is another agent used tosterilize surgical instruments. Hydrogen peroxide is vaporizedexternally from the sterilization chamber in a defined reaction chamber.The vaporized hydrogen peroxide is introduced into the sterilizationchamber, at which point it contacts the sterile barrier and passesthrough the barrier to contact the contents of the container to besterilized. The hydrogen peroxide vapor is introduced into asterilization chamber containing the articles to be sterilized. Hydrogenperoxide sterilizers today typically operate at much lower temperaturesthan steam sterilizers with maximum temperatures being around 122degrees Fahrenheit for a hydrogen peroxide sterilizer. A minimumhydrogen peroxide concentration, pressure changing “pulse cycle”, andtemperature relationships over time are required to be maintainedthroughout all portions of the load to complete sterilization. After thehydrogen peroxide vapor cycle has been completed, the chamber is purgedof residual and condensed hydrogen peroxide. RF energy may be used toenergize the residual hydrogen peroxide vapor during this aeration phasecreating a plasma that facilitates the aeration process. Some olderplasma systems utilized RF energy during the sterilant exposure phasewith the expectation that the plasma phase would be more effective atkilling micro-organisms than the vapor phase. Residual hydrogen peroxideis required to be removed from the surgical instruments and packagingprior to use in order to prevent burns and injury to healthcare workersand patients.

Other liquid and gaseous agents can also be used to sterilize surgicalinstruments such as ethylene oxide gas, formaldehyde gas and ozone gas.These sterilizing agents use “low temperature” sterilization conditionsas do the Hydrogen Peroxide sterilizers described above allowing theiruse on sensitive medical equipment as an alternate to potentiallydamaging high temperature steam sterilization. Unfortunately, thesegases are somewhat higher in toxicity and/or are difficult to controlduring the sterilization process so they do not enjoy wide-spread usethroughout hospital systems.

Regulations within the medical device industry require the OriginalEquipment Manufacturer (OEM) to provide instructions to the Hospitalsand Health care providers on proper use and maintenance of reusablemedical equipment. The OEM can be the designer, manufacturer ordistributor of reusable medical equipment. Within the category ofreusable medical equipment, certain equipment and instruments can becomecontaminated by biological material from the patient like bodily fluids,mucus and tissue during use so that it must be cleaned and/or sterilizedbefore being used again. Certain reusable medical equipment such asColonoscopes cannot be sterilized using the equipment in a hospitalcentral processing department. Based on the risks versus benefitsanalysis sterilization can be replaced by high level disinfection forthese devices. The generally accepted definition of a sterilizationprocess is, “the reduction of 10^6 organisms down to zero”, and highlevel disinfection process is, “the reduction of 10^3 organisms down tozero”. Sterilization is defined as the Sterility Assurance Level (SAL)which utilizes the, “overkill method”, to show a 12 log reduction of themost challenging organism to the method of sterilization being employed.A 12 log reduction means that there is a one in one million probabilityof a single viable organism surviving the sterilization process.Disinfection is defined in three categories; High Level Disinfection(HLD): Many or all pathogenic microorganisms with the exception ofbacterial spores, Intermediate Level Disinfection (ILD): May be cidalfor mycobacterium, vegetative bacteria, most viruses, and most fungi;but does not necessarily kill bacterial spores, and Low LevelDisinfection (LLD): Kill most vegetative bacteria, some fungi, and someviruses. The OEM is responsible to provide proper cleaning andsterilization (or disinfection) instructions to the Health Care users.The OEM is not allowed to randomly select cleaning and sterilizationtechniques prior to selling new reusable medical equipment, they arerequired to validate the cleaning and sterilization processes. For steamsterilization validations OEMs can use the American National StandardANSI/AAMI ST79 in the United States and ISO 17665-1 in other countries.These mentioned standards are incorporated by reference to this patentapplication. These standards include sterilization (or disinfection)validation testing protocols for the OEMs regarding the cleaning andsterilization methods so that Health Care facilities do not have toindividually validate these methods using their sterilization equipmentfor each medical device they purchase. Even though these standards areaccepted throughout the medical device industry by the HealthcareRegulatory agencies and the Healthcare providers, there is potential forhuman error, uncontrollable variability and sterilizing system equipmentproblems that enter into the Healthcare delivery system which may causeinconsistencies in the sterilization or disinfection results forreusable medical equipment. Examples: the OEM validates a new set ofequipment per the governing standards. The governing standards requirethat organism X be used to inoculate the new set of equipment for agiven sterilization agent. The OEM follows the governing protocols andvalidates the new equipment to a 10E-6 Sterility Assurance Level (SAL)using these nominal steam process values in a small chamber steamautoclave able to hold only one set of equipment (e.g. 14″×14″×24″chamber). The OEMs instructions resulting from the SAL validation couldbe as follows: Wrapped using 500 grade wrap, Dynamic air removal(pre-vac)cycle, Sterilization temp 132° Celcius, Exposure time 4minutes, Dry time 30 minutes. The hospital sets up the sterile barriersystem and follows all instructions, but instead of a single containerautoclave, they have a large steam autoclave where the chamber can hold40 sterile barrier system containers and a wheeled shelving rack wherethey roll the loaded rack into the autoclave. Uncontrolled variable: TheOEM validated their equipment in an ambient temperature of 25° C.(pre-sterilized equipment started at 25° C.) and the hospital storestheir pre-sterilized equipment in a conditioned environment at 20° C.Thermodynamically, the lower starting temperature and a significantlylarger total chamber load at the hospital reduces the actual exposuresteam/temperature duration below the validated level for proper organismdestruction. Human error: the Hospital followed all instructionsproperly, but a heavy medical instrument that did not have a containerwas included inside the sterile barrier system. This caused a reductionof the temperature build up of all equipment inside the sterile barriersystem. Sterilization equipment problem example: a power spike advancesthe sterilizer by 1 minute thus shortening the actual exposure durationby that amount. Similar examples can be established for othersterilization processes such as Hydrogen peroxide sterilizationprocesses and methods. Another factor that can cause problems with thesterilization of medical devices is where a mixed load of equipment issterilized together in a single process. The mixed load in this exampleis medical equipment that has the same sterilization time duration, butdifferent dry times across the various containers which are sterilizedtogether. If this occurs, there could be some residual moisture retainedin the equipment that requires a longer drying time. This residualmoisture can wick out. This wicking out results in a water stain formingon the SBS wrap used on a perforated container, but the water stain isnot discovered until the operating room personnel are preparing theequipment for the next surgical procedure. Once the operating roompersonnel notice the water stain during set-up, they have to return allof the equipment for reprocessing to the sterile processing department.The SBS materials are not designed to maintain their anti-microbialproperties if they become wet. Since it is not known when or how itbecame wet, the entire group of equipment becomes suspect due to thewater stain and thus must be reprocessed. These are some examples ofproblems that desire a better system and solution so that healthcaredelivery is efficient and safe.

Further, the current practice is to, as part of the process ofsterilizing a surgical instrument, perform a test to verify that thesterilizer in which the instrument is sterilized is properlyfunctioning. This test is performed with a biological indicator. Abiological indicator includes known number and type of microorganismsthat have an appreciable resistance to the mode of sterilization beingpracticed.

The biological indicator is placed in a tray or container and isprocessed through a specific sterilization process. The biologicalindicator can be placed within a sterile barrier and wrap prior toprocessing such that its exposure to the sterilant is similar to asurgical tool set. Many biological indicators used today are selfcontained. The self contained biological indicators have a housingsealed to a microbial barrier material that allows a path for thesterilizing agent to penetrate and reach the biological agent, but notallow other micro-organisms to enter. These biological indicators do notrequire a container or wrap during use.

Therefore, there are typically different biological indicators for eachsterilization process modality used in a sterile processing department.This requires the sterile processing department to be trained toproperly execute the biological indicator tests for every sterilizer andsterilizing modality within the department. For example if a hospitalhas both autoclave steam and hydrogen peroxide equipment, the sterileprocessing department has to purchase and maintain both types ofbiological indicators and be trained to properly process the biologicalindicators. Also, the different manufacturers of hydrogen peroxideequipment typically each require a specific biological indicator be usedin this test. So if a sterile processing department has two hydrogenperoxide systems, each made by a different manufacturer, the sterileprocessing department needs to become proficient at operating twobiological indicator tests, one for each system. Bacterial spores havebeen used as biological indicators. The biological indicator is sealedor enclosed in a protective package. After exposure to the sterilizationprocess, the biological indicator is placed in a growth medium andcultivated for a period of time, after which they are read by departmentpersonnel. For example, steam autoclave biological indicators useGeobacillus stearothermophilus at a 10⁶ population and are incubated fora minimum of 24 hours in a growth medium. For Hydrogen Peroxidesterilization agents, a Geobacillus stearothermophilus at a 10⁶population is used and incubated in a growth medium at a specifictemperature for 24 hours. Subsequent growth of the biological agentindicates a failure of the sterilization process and subsequent nogrowth of the biological agent microorganisms under suitable conditionsindicates the proper operation of the sterilization process for thatparticular cycle. Because the biological agent used in biologicalindicators are more resistant to their specific sterilization agentsthan common microorganisms potentially found on surgical instruments,the demonstration that the biological indicator has been inactivatedprovides assurance that other microorganisms, including potentialpathogens in the load, have also been destroyed.

For Hydrogen peroxide sterilizers, a typical sterile processingdepartment runs a biological indicator test every 24 hours as a check onthe proper operation of the equipment. The biological indicator test istypically run by itself or with the first lot of medical equipmentprocessed through the sterilizer machine for the day. A biologicalindicator test can take up to 24 hours to complete. Consequently,subsequent loads of surgical instruments and tools are quarantined forthe time period required to complete the biological indicator test so asto verify that the sterilizer is properly functioning.

Many sterilization processes take less than an hour to perform. However,owing to the need to verify that the sterilizer is properly functioning,an instrument can be quarantined for up to the additional 24 hoursrequired to obtain the results of the biological indicator test. Thismeans that at a hospital, at any given moment in time, a significantnumber of the hospital's surgical instruments may be in quarantine. Thisrequires the hospital to have a large inventory of surgical instrumentsso that, at any given instant, a sufficient number of instruments aresterilized and ready for use. Requiring the hospital to maintain thislarge inventory of instruments can add to the cost of maintaining thehospital.

If the biological indicator test fails, all of the lots of surgicalequipment processed in the sterilizer machine, since the last passedbiological indicator test, are potentially non-sterile. This equipmentis then reprocessed again through the cleaning and sterilizationprocess.

If first biological indicator test indicates the sterilizer is operatingproperly, it is assumed that the sterilizer has sterilized theinstruments placed in the sterilizer up until the execution of the nextbiological indicator test. This assumption is made even though there isa possibility that between the two consecutive tests, the sterilizer maystart to malfunction. The fact that the sterilizer may have startedmalfunctioning is not known until the results of the second biologicalindicator tests are read. In the interim, however, the equipmentsterilized between the first and second tests may have been releasedfrom quarantine and used in a procedure. This means the equipment usedon a patient may be a piece of equipment that was not properlysterilized.

Further, having to execute a biological indicator test requiresresources include the time of hospital personnel.

The current processes for determining the proper operation of thevarious sterilizing equipment's sterilization processes and the use ofmicrobial barriers for subsequent storage have many problems that addtime and expense to the entire sterilization process. The use ofmicrobial barriers and wraps to encase surgical instruments adds expensein the purchase of the materials and time for department personnel towrap and create the sterile barrier containing the surgical instruments.The use of microbial barriers also increases the difficulty of thesterilant to enter the wrapped package and complete sterilization,particularly for low vapor pressure sterilants such as hydrogen peroxidevapor. Variations in sterile barrier materials and how they are appliedwill introduce variation in the sterilant concentration within thewrapped package. Variations in the mass, materials of construction, andsurface area of the instrument load can also introduce variation in thesterilant concentration within the wrapped package.

The use of chemical indicators adds expense in the purchase of thechemical indicators and the time for department personnel to place andread the chemical indictors. The use of biological indicators addsexpense in the purchase of the biological indicators and the time fordepartment personnel to place, incubate and subsequently read theresults of the biological indictor.

If either of the chemical or biological indicator tests fail, all of theunused lots of surgical equipment processed in the sterilizer machine,since the last acceptable test, must be reprocessed again through thecleaning and sterilization process, adding time, expense and increasingthe inventory of surgical instruments required. As discussed above,there is a possibility that instruments that may not have beensterilized were used on patients. If this event occurs appropriateaction may need to be taken. In addition, if the sterilizer has anequipment or process problem during one biological incubation period,this problem may not be detectable until the reading at the end of thesubsequent biological indicator (BI) incubation period (by reading afailed biological indicator in the subsequent test). This allows thepossibility of releasing medical equipment from quarantine from the timethe problem occurs (during the first incubation period) until the timeof the failed BI test.

Another problem with the current processes for determining the validityof a sterilization process is that many of the steps in the processdepend upon human action and judgment and as such are prone to humanerror. Human error can occur by incorrect orientation and placement ofsurgical instruments in racks and containers. Human error can occur byplacing items so that they block the flow of sterilant into thecontainer and adversely affect sterilization efficacy of the itemstherein. Human error can occur by placing too many instruments withinthe container adversely affecting sterilization efficacy. Human errorcan occur by stacking containers on top of one another so that thesterilant is not able to flow freely into all of them. Human error canoccur by incorrectly operating the sterilization machine. Human errorcan occur by incorrect placement and reading of chemical indicators.Human error can occur by incorrect placement, incubation, and reading ofbiological indicators.

SUMMARY OF THE INVENTION

This invention is directed to a new and useful system and method fordetermining if surgical instruments have completed a sterilizationprocess cycle and have met a set of required process measurements duringthe sterilization process cycle. The system includes a container definedby several panels. The panels define a cavity within the container andan opening into the container. The container receives surgicalinstruments that may be within a removable insert tray into the cavity.A cover is coupled to the container and is movable between an openposition and a closed position. A sensor module is mounted to thecontainer. The sensor module includes one or more sensors. The sensorsare configured to and positioned to monitor at least one characteristicof the environment inside the container. The sensor module includes aprocessor with instructions regarding how to interpret the environmentals obtained from the sensors.

The container of instruments is placed within a sterilization chamber,the chamber door is closed and a sterilization cycle performed. Thesensors monitor the changes in the characteristics of the containerenvironment as a result of the sterilization cycle. The processorcompares the environmental measurements taken by the sensors withinpreviously validated sterilization process measurements. These validatedsterilization process measurements are measurements of the containerenvironment taken during previous sterilization processes in whichsubsequent testing has shown were successful.

If the evaluation of the environment measurements indicates that theenvironment within the container was sufficient to affect successsterilization of the instruments, the processor indicates that thesurgical instruments were successfully sterilized. Alternatively, theevaluation may indicate the container environment was not an environmentin which it can be certain that the instruments in the container weresterilized. If this is the result of evaluation, the processor presentsan indication that the instruments were not properly sterilized.

A benefit of this system is that soon after the sterilization process isperformed, an indication is provided regarding whether or not theinstruments were exposed to a process in which they were properlysterilized.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is pointed out with particularity in the claims. The aboveand further features and advantages of the invention are understood bythe following Detailed Description taken in conjunction with theaccompanying drawings in which:

FIG. 1 is a diagrammatic view of a sterilization chamber used forsterilization of medical/surgical instruments;

FIG. 2 is a top perspective view of a container used for sterilizationof medical/surgical instruments of this invention showing the containerseparated from the cover and an instrument rack in accordance with oneembodiment;

FIG. 3 is an enlarged perspective view of the container of FIG. 2illustrating the electronic sensor module separated from the containerin accordance with one embodiment;

FIG. 4A is a rear view of the electronic sensor module in accordancewith one embodiment;

FIG. 4B is a front view of the electronic sensor module;

FIG. 4C is a front cut-away view of the electronic sensor module;

FIG. 4D is a bottom view of the module of FIG. 4A;

FIG. 5 is a top perspective view of an automatic closing container usedfor sterilization of medical/surgical instruments with the cover in anopen position in accordance with one embodiment;

FIG. 6 is a top perspective view of the automatic closing container ofFIG. 5 with the cover in a closed position;

FIG. 7A is an exploded top perspective view of another container forsterilization of medical/surgical instruments having a false bottom inaccordance with one embodiment;

FIG. 7B is an enlarged partial cross-sectional view of the cover of FIG.7A;

FIG. 7C is an enlarged cross-sectional view of one side wall embodimentof the container of FIG. 7A illustrating details of a hermetic connectorand internal light emitting diodes;

FIG. 7D is an enlarged cross-sectional view of another side wallembodiment of the container of FIG. 7A illustrating details of ahermetic connector and external light emitting diodes;

FIG. 8 is an exploded top perspective view of an additional containerfor sterilization of medical/surgical instruments having a false side inaccordance with one embodiment;

FIG. 9A is an exploded top perspective view of yet another container forsterilization of medical/surgical instruments having sensors mounted inthe cover in accordance with one embodiment;

FIG. 9B is a bottom view of the cover of FIG. 9A;

FIG. 10 is an exploded top perspective view of one more container forsterilization of medical/surgical instruments having sensors mounted toa tray or rack in accordance with one embodiment;

FIG. 11A is an exploded top perspective view of one more container forsterilization of medical/surgical instruments having a removable opticalsensor module in accordance with one embodiment;

FIG. 11B is an assembled top perspective view of the removable opticalsensor module of FIG. 11A;

FIG. 11C is an assembled top perspective view of the container of FIG.11A;

FIG. 12A is a top perspective view of a sensor printed circuit board forsensing steam concentration and other characteristics of the environmentin the container in accordance with one embodiment;

FIG. 12B is a top perspective view of another sensor printed circuitboard for sensing hydrogen peroxide concentration and otherenvironmental characteristics in accordance with one embodiment;

FIG. 12C is a top perspective view of a sensor printed circuit board forsensing hydrogen peroxide concentration and other environmentalcharacteristics in accordance with one embodiment;

FIG. 13 is an electrical block diagram of the electronic sensor modulein accordance with one embodiment;

FIG. 14 is a block diagram of software programs or sets of instructionsstored by a memory or machine readable medium in accordance with oneembodiment;

FIG. 15 is a perspective view of a docking station for use with acontainer in accordance with one embodiment;

FIG. 16 is a perspective view of another docking station that includessensor calibration for use with a container in accordance with oneembodiment;

FIG. 17 is a block diagram of the controller of the docking stations ofFIGS. 16 and 17;

FIG. 18 is a diagrammatic view of a networked computer system fortracking container usage and billing in accordance with one embodiment;

FIGS. 19A-1 and 19A-2, when placed side-to-side, collectively form atable of equipment to be sterilized; validated sterilization processmeasurements for the equipment; sensor module usage data; sterilizerprocess nominal parameters; and container identification data;

FIGS. 19B-19E are lists of equipment that can be sterilized based onspecific content identifiers and the weights of at least some of theequipment;

FIG. 20A is a perspective view of an automatic closing lid cap mountedto a container cover in accordance with one embodiment;

FIG. 20B is a cross-sectional view of the automatic closing lid cap ofFIG. 20A;

FIG. 20C is an exploded perspective view of the automatic closing lidcap of FIG. 20A;

FIG. 21 is flowchart of a method of determining if validatedsterilization process measurements within a container have been achievedduring a sterilization process in accordance with one embodiment;

FIG. 22 is flowchart of a method of validating container environmentalmeasurements in accordance with one embodiment;

FIG. 23 is flowchart of another method of determining and validatingsterilization process measurements in accordance with one embodiment;

FIG. 24 is flowchart of an additional method of determining andvalidating sterilization process measurements in accordance with oneembodiment;

FIG. 25 is flowchart of a method of monitoring sterility of a containerassembly in accordance with one embodiment;

FIG. 26 is flowchart of a method of loading surgical instruments into acontainer assembly prior to sterilization in accordance with oneembodiment;

FIG. 27 is flowchart of a method of calibrating sensors in accordancewith one embodiment;

FIG. 28 is flowchart of a method of monitoring container usage andbilling on a fee per use basis in accordance with one embodiment;

FIG. 29 is top perspective view of a container and cover forsterilization of medical/surgical instruments that includes a removablesensor assembly in accordance with one embodiment;

FIG. 30 is a cross sectional view of the container of FIG. 29illustrating the removable sensor assembly mounted to the container;

FIG. 31 is an exploded perspective view of the removable sensor assemblyof FIG. 29;

FIG. 32 is an exploded cross-sectional perspective view of the removablesensor assembly of FIG. 29;

FIG. 33 is an enlarged cross sectional view of the receiver housing;

FIG. 34 is an enlarged cross sectional view of the receiver cover andretaining ring;

FIG. 35 is an enlarged cross sectional view of the carriage assembly;

FIG. 36 is an enlarged cross sectional view of the removable sensormodule;

FIG. 37A is a rear view of the removable sensor module printed circuitboard;

FIG. 37B is a front view of the removable sensor module printed circuitboard;

FIG. 38 is a front view of the container printed circuit board;

FIG. 39 is an assembled cross sectional view of the removable sensorassembly illustrating the removable sensor module separated from thereceiver;

FIG. 40 is an assembled cross sectional view of the removable sensorassembly illustrating the removable sensor module seated in an initialposition in the receiver;

FIG. 41 is an assembled cross sectional view of the removable sensorassembly illustrating the internal locking mechanism being actuated andopening of the plate to expose the sensors to the internal containerenvironment;

FIG. 42 is an assembled cross sectional view of the removable sensorassembly illustrating the removable sensor module in the locked positionand ready to collect data during a sterilization process cycle;

FIG. 43 is an assembled cross sectional view of the removable sensorassembly illustrating closing of the plate and removing the removablesensor module from the receiver;

FIG. 44 is a perspective view of docking station that includes sensorcalibration for use with the removable sensor assembly of FIG. 29 inaccordance with one embodiment;

FIG. 45 is flowchart of a method of determining if validatedsterilization process measurements within a container have beencompleted using the container and removable sensor assembly of FIG. 29in accordance with one embodiment;

FIG. 46 is an exploded top perspective view of an automatic closingcontainer assembly used for sterilization of medical/surgicalinstruments in accordance with one embodiment;

FIG. 47 is an enlarged top perspective view of a scissors lift mechanismwithin the automatic closing container assembly of FIG. 46;

FIG. 48 is an enlarged cross-sectional view of a moveable frame andcontainer; and

FIG. 49 is flowchart of a method of determining if validatedsterilization process measurements taken within a container have beenmet or exceeded using the automatic closing container assembly of FIG.46 in accordance with one embodiment.

FIG. 50 is flowchart of a method of determining if verifiedsterilization process parameters within a container have been met duringa steam sterilization process in accordance with one embodiment;

FIG. 51 is a graph of an example of measured steam process measurementsversus time for the method of FIG. 50;

FIG. 52 is flowchart of a method of determining if verifiedsterilization process parameters within a container have been met duringa hydrogen peroxide sterilization process in accordance with oneembodiment; and

FIG. 53 is a graph of an example of measured hydrogen peroxide processmeasurements versus time for the method of FIG. 52.

DETAILED DESCRIPTION I. Overview

FIG. 1 illustrates a sterilization apparatus 50 used for sterilizingmedical and surgical instruments. Sterilization apparatus 50 comprises asterilization chamber 52 that holds one or more sterilization containers58. Each container 58 can hold one or more surgical instruments that aredesired to be sterilized. Sterilization chamber 52 includes acontainment vessel 54 that can be sealed after door 56 is closed.Containment vessel 54 has one or more shelves 60. Containers 58 arearranged on shelves 60.

Sterilization chamber 52 further includes a vacuum pump 64. Vacuum pump62 can decrease the pressure within containment vessel 54 to belowatmospheric pressure. A sterilization agent or sterilant is injectedinto containment vessel 54. Various sterilants can be used includinggaseous water vapor or steam (H₂O) 70, hydrogen peroxide gas (H₂O₂) 74or gaseous ethylene oxide (C₂H₄O) 74. At least one of the sterilizationagents are introduced into containment vessel 54 during a sterilizationcycle.

During a sterilization cycle, the sterilant is required to come intocontact with the all of the surgical instruments with the containmentvessel 54 at a required concentration for a required time to affectsterilization of the surgical instruments. After the sterilization cyclehas been completed, the sterilization chamber must be purged of anyresidual or condensed sterilant. The removal rate of sterilant from thechamber is increased by the use of vacuum pump 64. Drawing a vacuumwithin containment vessel 54 causes any condensed sterilant to evaporateinto a gaseous state and be removed.

Sterilization chamber 52 is operated using a set of chamber processparameters (CPP) 66. CPP 66 are the environmental operating conditionsgenerated within containment vessel 54 by sterilization apparatus 50. Inone example embodiment, CPP 66 includes temperature, pressure, humidity,hydrogen peroxide vapor and time.

II. First Container Embodiment

Turning to FIG. 2, a container assembly 90 of a first embodiment of thisinvention is illustrated. Container assembly 90 includes a container 100that is generally rectangular in shape and is defined by an opposedspaced apart planar front panel 102, a planar rear panel 103 and a pairof opposed spaced apart planar side panels 104. Panels 102 and 103 areoriented orthogonal to panels 104. A planar bottom panel 106 isperpendicular to panels 102, 103 and 104 and forms the bottom ofcontainer 100. An interior cavity 120 is defined by panels 102, 103, 104and 106 within container 100. Container 100 has outer surfaces 110,inner surfaces 112 and an upper peripheral rim 113. Container 100 can beformed from materials such as stamped or deep drawn aluminum, stainlesssteel, plastic or other suitable materials.

Front panel 102 has a window or opening 114 defined therein. Opening 114is covered by a panel 116 formed from a material that is transparentsuch as acrylic or glass. Transparent panel 116 allows a user tovisually see the contents of container 100. Panel 116 is sealed to theadjacent panel 102. Panel 116 is located on front panel 102, but may belocated on back panel 103 or side panels 104.

Each of side panels 104 has a recessed portion 122 defined in outersurface 110 that extends from just above bottom panel 106 to just belowrim 113. A series of holes 124 are defined through recessed portion 122and extend into cavity 120. A pivoting handle 126 is attached to eachside panel 104 and extends across the width of recessed portion 122.Handle 126 pivots between a stored position where handle 126 is adjacentrecessed portion 122 (shown in FIG. 2) and a carrying position wherehandle 126 extends perpendicular to side panel 104. Handle 126 allows auser to grasp and lift container 100.

A pivoting latch 128 is attached to each side panel 104 below rim 113 bya hinge 130. Latch 128 has a U-shaped bail portion 132 that mates with aportion of cover 150. Latch 128 allows a user to releasably lock cover150 to container 100. A pair of spaced apart L-shaped side rails 136 aremounted to inner surface 112 on opposite sides of recessed portion 122and extend perpendicular away from inner surface 112 towards cavity 120.An L-shaped bottom rail 137 is mounted between the ends of rails 136 atthe bottom of recessed portion 122. A bar code or RFID tag 135 (FIG. 3)is mounted to outer surface 110 of side panel 104. Bar code or RFID tag135 can contain information about container assembly 90 such as the typeof container or the contents of container 100.

Filter assemblies 140 are mounted in cavity 120 adjacent inner surfaces112 of side panels 104. Each filter assembly 140 is supported andretained by L-shaped rails 136 and 137. Filter assembly 140 covers holes124. Filter assembly 140 is generally square in shape and has a squareframe 142 and a filter material 144 mounted within frame 142. Filtermaterial 144 is a microbial barrier material that is permeable tosterilant. Here “sterilant” is understood to be a gas, vapor or aerosolthat has ability to render biological contaminates includingmicroorganisms innocuous. Filter material 144 allows sterilant to passfrom the outside of container 100 through holes 124, through filtermaterial 144 and into interior cavity 120 where the sterilant cancontact the surgical instruments 180. Filter material 144 also forms amicrobial barrier preventing microorganisms from entering into container100 after container 100 has been processed through a sterilizationprocess.

Filter assembly 140 is placed by a user inserting and sliding frame 142along side rails 136 until frame 142 abuts bottom rail 137. Rails 136and 137 are dimensioned to force filter assembly 140 to be compressedagainst the inner surface 112 of side panel 104 when inserted into rails136 and 137. Rails 136, 137 and frame 142 are dimensioned such that whenfilter assembly 142 is mounted in container 100, a seal is formedbetween the outer periphery of frame 142 and inner surface 112. Filterassembly 140 is sealingly mounted to the inner surface 112 of container90 to form a continuous microbial barrier with the adjacent panel innersurface 112.

Cover 150 is used to cover and enclose container 100. Cover 150 includesa generally rectangular shaped frame 152 that surrounds a transparentwindow panel 154. Cover 150 has a top surface 155 and a bottom surface156. Frame 152 can be formed from materials such as stamped aluminum orother suitable materials. Transparent panel 154 formed from a materialthat is transparent such as acrylic or glass. Transparent panel 154allows a user to visually see the contents of container 100. A pair ofblocks 157 are mounted to opposite sides of frame 152. Each block 157has defined therein a linear groove 158 that extends the length of block157. Bail portion 132 of latch 128 mates with groove 158 in order toretain cover 150 to container 100. Bail portion 132 is placed intogroove 158 and latch 128 is pivoted downward to a locked position wherecover 150 is removable and sealingly locked to container 100. Anelastomeric seal (not shown) is mounted to the cover frame 152. When thecover 150 is installed on container 100, the elastomeric seal preventsmicro-organisms from entering the interior of the cover and container100 by sealing the gap between the cover and upper peripheral rim 113 ofcontainer 100, thus completing an enclosure to keep micro-organisms fromentering the interior where the surgical instruments 180 are located.

A rack or insert tray 160 is used to hold medical/surgical instruments180 within container 100 during sterile processing. Rack 160 includes agenerally rectangular shaped base 162 with four walls 164 that extendperpendicularly upward from base 162. A pair of spaced apart handles 165are mounted to opposing walls 164 allowing a user to lift rack 180.Apertures 166 are defined in base 162. Several support members 168extend upwardly from base 162.

Medical/surgical instruments 180 rest on and are supported by supportmembers 168. Support members 168 are dimensioned and shaped so thatmedical/surgical instruments 180 are retained in a preferred orientationfor sterile processing.

In one embodiment, medical/surgical instruments 180 can be manualinstruments such as scalpels, forceps and osteo-tomes. In anotherembodiment, medical/surgical instruments 180 can be powered instrumentssuch as rotary handpieces, drills, or endoscopes. Reusablemedical/surgical instruments require cleaning and sterilization prior tore-use to destroy microorganisms that may be present. Medical/surgicalinstruments 180 with dead end lumens need to be oriented with the lumenhorizontal or pointing downward during automated washing and sterileprocessing such that liquids do not accumulate in the lumen and so thatsterilant can enter and exit from the lumen.

An electronic sensor assembly or module 200 is mounted to front panel102 below window 114. Electronic sensor module 200 contains electroniccomponents and sensors that measure environmental conditions incontainer 100. These components also determine if required conditionshave been met to insure sterility of the contents of container 100.Electronic sensor assembly 200 can be mounted to other container panelssuch as back panel 103 side panel 104 or cover 150.

With reference to FIG. 3, further details of container 100 andelectronic sensor module 200 are illustrated. Container 100 furthercomprises a raised section 190 that extends upwardly from the base ofwindow 114. Ramp sections 192 extend between the base of window 114 andraised section 190. A pair of spaced apart holes 194 are defined inpanel 116. An opening 196 is defined in transparent panel 116 aboveraised section 190 and between holes 194.

Electronic sensor module 200 includes a generally trapezoidal shapedhousing 202 that has a front side 204, rear side 206, top side 208,bottom side 210 and angled sides 212. Housing 202 can be formed from anysuitable material such as injection molded plastic, aluminum orstainless steel. A pair of threaded studs 220 extend perpendicularlyaway from rear side 206.

Electronic sensor module 200 is mounted to container 100 by placinghousing 202 above raised section 190 and inserting studs 220 throughholes 194. Washers 224 are placed over studs 220 and fasteners 224 suchas a nut are threaded onto studs 220 securing electronic module 200 tocontainer 100. Gasket, seals or a curable sealing material 214 are usedbetween sensor module 200 and container 100 to prevent micro-organismsfrom entering the interior of the container through mounting holes 194or opening 196. In this position rear side 206 of electronic module 200abuts transparent panel 116 and extends over opening 196. Electronicmodule 200 can be retrofitted to various existing types of containers bymodifying the existing containers to include holes 194 and opening 196.

A green light emitting diode (LED) 230, a red LED 232 and a yellow LED233 are mounted within housing 202 and are visible through an opening infront side 204. In another embodiment, LEDs are replaced with anothervisual type of indicator pane or display. These alternate embodimentsprovide a visual status of the equipment load, the sensor modules orother items that are helpful visual indicators to the operators usingthese systems during disinfection or sterilization processes. A display234 such as a liquid crystal display is mounted within housing 202 aboveLEDs 230-233 and is visible through an opening in front side 204. LEDs230-233 and LCD 234 provide visual information to personnel usingcontainer 100.

A bar code, UPC code or RFID tag 135 is mounted to front side 124. Barcode or RFID tag 135 can contain information about electronic module 200such as the type of electronic module and/or the contents of container100. Bar code or RFID tag 135 can be optionally located on otherexterior panels of container 100 or on sensor module 200.

Referring to FIGS. 4A, 4B and 4C, further details of electronic sensormodule 200 are illustrated. A battery compartment 215 is located on rearside 206. Battery compartment 215 contains a battery 216 that is mountedbetween terminals 217 and 218. A cover 219 is snap fit to housing 202covering battery compartment 215. Battery 216 provides power toelectronic module 200. Connector terminals 243 and 244 are used toconnect to devices external to electronic module 200. For example,connector terminals 244 are connected with battery 216 and can beconnected to a source of power in order to recharge battery 216.Connector terminals 243 can be used to transmit and receive data betweenelectronic module 200 and an external device.

An opening 226 is located in the back side 206 of housing 202. Severalsensors 240 are coupled to a printed circuit board 242 that is mountedwithin housing 202. Sensors 240 are visible or exposed through opening226. Sensors 240 measure environmental characteristics such astemperature, pressure, humidity and chemical concentration levels. Whenhousing 202 is mounted to container 100, sensors 240 are positioned overopening 196 such that sensors 240 are exposed to the environmentalconditions within interior cavity 120. In one embodiment, sensors 240can extend through opening 196 into interior cavity 120.

Other electronic components are mounted to printed circuit board 242 asseen in FIG. 4C to allow electronic module to monitor thecharacteristics of the environment in container 100. A processor 250 andmemory 252 are mounted to printed circuit board 242. A wireless module254 and passive components 256 are mounted to printed circuit board 242.Wireless module 254 allows electronic module 200 to communicate withother external devices. These devices include transceiver heads andcomputer systems. In one embodiment, wireless module 254 can transmitand receive data and instructions from other external computer systemsand networks.

A green light emitting diode (LED) 230, a red LED 232 and a yellow LED233 are mounted to printed circuit board 242. Alternately, these threeLEDs can be replaced by a multi-colored LED assembly to produce one ormore distinctively different colors. These distinctively differentcolors provide information to the user as to the status of thecontainer. For example red LED 232 can indicate the container ofequipment is non-sterile. The yellow LED 233 can indicate the containerof equipment is ready to be sterilized. The green LED 230 can indicatethe container of equipment has been properly sterilized. A display 234such as a liquid crystal display can be mounted to printed circuit board242. LEDs 230, 232, 233 and LCD 234 provide visual information topersonnel using container 100.

III. Second Container Embodiment

FIG. 5 illustrates a container assembly 300 of a second embodiment ofthe present invention. In FIG. 5, common reference numbers to like itemsin FIG. 2 have been given the same reference number. Container assembly300 includes a container 302 that is generally rectangular in shape.Container 302 is similar to container 100; however, some features ofcontainer 100 have been omitted and other features have been added. Forexample, container 302 does not include any holes 124 or a filterassembly 140.

Electronic module 200 is mounted to front panel 102. Electronic sensormodule 200 contains electronic components and sensors that measureenvironmental characteristics within container 302 and determine ifrequired conditions have been met to insure sterility of the contents ofcontainer 302.

Container 302 further includes four rounded shoulders 304. Each ofshoulders 304 is located at an interior corner 306 of container 302 andextends along the length of corner 306 between bottom panel 106 and rim113. A bore 308 is defined in each shoulder 304 and extends into aninternal compartment 310. A linear actuator 312 is mounted in each ofcompartments 310. Each linear actuator 312 is in communication withelectronic module 200 through an electrical cable 314.

A cover 350 is used to cover and enclose container 302. Cover 350includes a generally rectangular shaped frame 352 that surrounds atransparent window panel 354. Cover 350 has a top surface 355 and abottom surface 356. An elastomeric gasket 357 is mounted to bottomsurface 356 and makes a seal when mated with rim 113 when cover 350 isin a closed position. Control buttons 358 and 359 are mounted to thefront top surface of frame 352 and are in communication with electronicmodule 200 through wireless communication means (not shown). Controlbutton 358 closes cover 350 and control button 359 opens cover 350.

Four rods 360 are coupled between cover 350 and linear actuators 312.Rods 360 have a proximal end 362 and a distal end 364. Proximal end 362is located in compartment 310 and connected to linear actuator 312. Rod360 extends through bore 308 terminating at distal end 364. Distal end364 is removably coupled to frame 352. Electronic module 200 triggerslinear actuator 312 to move rods 360 and cover 350 in a linear directiontoward and away from container 302.

Cover 350 can be attached and detached from rods 360 in order tofacilitate loading and unloading of container 302. Four quick releasepin 372 are inserted through apertures 374 located in each interiorcorner of frame 352. Quick release pin 372 mates with a bore (not shown)in the distal end 364 of rod 360 in order to retain frame 352 to distalend 364. Each quick release pin 372 has one or more ball bearings (notshown) that are biased outwardly by an internal spring. When all fourquick release pins 372 are removed, cover 350 can be removed from rods360 allowing access to interior cavity 120. Medical personal canmanually place tray 160 and surgical instruments to be sterilized intocavity 120.

In an open position, as shown in FIG. 5, cover 350 is supported by rods360 and is spaced apart from rim 113. A gap or opening 370 is formedbetween frame 352 and rim 113. In the open position, sterilant can enterinto and exit from interior cavity 120 through opening 370 duringsterile processing.

Turning to FIG. 6, cover 350 is shown in a closed position sealingcontainer 302 and the contents of container 302 (i.e. rack 160 andsurgical instruments 180). After electronic module 200 determines thatthe operating conditions within container 302 during sterile processingwere sufficient to meet or exceed a required set of operatingconditions, electronic module 200 directs linear actuators 312 to closecover 350 and turns on green LED 230. The closing and sealing of cover350 and an “on” green LED 230 indicates the contents of the containerwere properly sterilized and the container properly sealed. Acontinuously “on” green LED 230 can alternately be a flashing “on” greenLED 230 so that the discharge rate of the battery can be slowed in orderto extend battery life.

In the closed position, gasket 357 is held against rim 113 forming aseal between frame 352 and container 302. The sealed container allowssterile instruments within the container to be removed from thesterilizer 50 while maintaining a sterile environment within container302 after processing. When surgical instruments 180 within closedcontainer 302 are required for a surgical procedure, a user depressesopen button 359 which causes electronic sensor module 200 to directactuators 312 to move cover 350 to the open position. The user thenmanually removes quick release pins 372 and cover 350 allowing access tointerior cavity 120 for removal of the sterilized surgical instruments180.

After cover 350 is opened, the environment within container assembly 300may no longer be sterile. When electronic sensor module 200 opens cover350, electronic sensor module also turns off green LED 230 and turns onred LED 232. The illumination of red LED 232 indicates to a user thatthe container seal has been broken. Inferentially this is an indicationthat the contents of the container are no longer sterile. If cover 350is opened and then closed, red LED 232 will remain lit informing a userthat the contents of the container are no longer sterile.

Container assembly 300 further optionally includes one or more tamperseals 376 (FIG. 6) in addition to tamper sensors 380 (FIG. 5). Tamperseals 376 and tamper sensors 380 are used to indicate if containerassembly 300 has been opened during storage causing the sterility of thecontents of container assembly 300 to be compromised. Tamper seal 376 isa tape or seal that is mounted between container 302 and cover 350.Removal or opening of cover 350 causes tamper seal 376 to be brokenindicating to a user the sterility of the contents of container assembly300 have been compromised.

Returning to FIG. 5, tamper sensor 380 may comprise a Hall effect sensor382 and a magnet 384. Hall effect sensor 382 is mounted to the top ofshoulder 304 adjacent to bore 308. Magnet 384 is mounted to the bottomside of frame 352. Hall effect sensor is in communication withelectronic module 200 through a cable 386 mounted within container 302.When cover 350 is in the closed position, magnet 384 is juxtaposed toHall effect sensor 382. Hall effect sensor 382 senses the magnetic fieldgenerated by magnet 384 and sends an electrical signal indicating thepresence of magnet 384 to electronic sensor module 200. Electronicmodule 200 can keep green LED 230 illuminated indicating to a user thatthe contents of container assembly 300 are sterile. When cover 350 ismoved away from container 302, breaking the sterile barrier created bythe container assembly 300, Hall effect sensor 382 sends an electricalsignal to electronic module 200 indicating a reduced magnetic fieldgenerated by magnet 384. Electronic module then turns off green LED 230and turns on red LED 232. The illumination of red LED 232 indicates to auser that the contents of container assembly 300 are no longer sterile.In order to extend the battery charge of battery 216, LEDs can flashproviding indications to the user as described above.

IV. Third Container Embodiment

Referring to FIGS. 7A-7D, a container assembly 400 of a third embodimentof the present invention is shown. With specific reference to FIG. 7A,container assembly 400 comprises a container 402 that is generallyrectangular in shape and is defined by a planar front panel 403, anopposed planar rear panel 404 and a pair of opposed spaced apart planarside panels 405 and 406. Panels 403 and 404 are oriented orthogonal topanels 405 and 406. A planar bottom panel 407 is mounted perpendicularto panels 403-406 and forms the bottom of container 402. An interiorcavity 420 is defined within container 402. Container 402 has outersurfaces 410 and inner surfaces 412. An upper peripheral rim 413 isdefined by the upper edges of panels 403-406. Container 402 can beformed from materials such as stamped aluminum or other suitablematerials.

Side panel 406 has an opening 414 that is covered by a panel 416 that istransparent to visible light but is opaque to infrared (IR) and/orultraviolet (UV) light frequencies. Panel 416 prevents external orinternal UV and/or IR light from passing through panel 416. Transparentpanel 416 allows a user to visually see the contents within container402. An elastomeric gasket 415 seals panel 416 to side panel 406. Gasket415 and panel 416 are attached to side panel 406 using an adhesive.

Another opening 418 is defined in side panel 406 extending from justabove bottom panel 406 to below opening 414. Opening 418 is smaller thanopening 414. Opening 418 is dimensioned to receive a window 421. Window421 can be either transparent or opaque and can be formed from a plasticmaterial. A gasket or hermetic seal 422 seals window 421 to side panel406. Gasket 422 and panel 421 are attached to side panel 406 using anadhesive.

A pivoting handle 426 is attached to each of side panels 405 and 406.Handle 426 has ends 425 that are retained to side panels 405 and 406 bycircular shaped bands 426. Two bands 426 are rigidly attached and sealedto side panel 405. Two bands 426 are rigidly attached and sealed to sidepanel 406. Ends 425 are received by bands 426 and can rotate withinbands 426. Handles 424 pivot between a stored position where handles 424are adjacent side panels 405, 406 and a carrying position where handles424 extend perpendicular to side panels 405, 406. Side panels 405, 406further include a pair of opposed L-shaped steps 496 that are mounted toopposite ends of container 402. More particularly, steps 496 extendgenerally perpendicularly away from opposed portions of flange 453 andare angled slightly downwardly. Steps 496 are used in conjunction withlocking lid latch 446, mounted to the cover 450 to secure cover 450 tocontainer 402. Locking lid latch 446 is rotated by a user downwardlyover steps 496 to a locked position where cover 450 is retained to andlocked to container 402 while compressing cover gasket 456 between cover450 and container 402. This compression inhibits the entry of microbesinto the container.

With additional reference to FIG. 7B, a cover 450 is used to cover andenclose container 402. Cover 450 includes a generally rectangular shapedpanel 452. Cover 450 can be formed from materials such as stampedaluminum or other suitable materials. Two arrays of holes 459 aredefined in and extend through panel 452. Holes 459 are located towardeach of the ends of panel 452. Holes 459 allow sterilant to enter andleave container 402 during sterilization processing. An outer peripheralflange 453 extends downwardly from the outer edges of panel 452. Arectangular interior wall 454 extends downwardly from panel 452 and isspaced inwardly from flange 453 along the entire length of flange 453.Flange 453 and wall 454 define a U-shaped groove 455 there between. Anelastomeric gasket 456 is mounted in groove 455. Cover 450 fits overpanels 403, 404, 405 and 406 such that rim 413 rests between flange 453and wall 454 and is in contact with gasket 456. Gasket 456 forms a sealbetween cover 450 and container 402. Wall 454 further defines aninterior recess 457 below panel 452. A pair of spaced apart opposedL-shaped rails 458 extend perpendicularly away from the bottom surfaceof panel 452 into recess 457. The terminal lips 451 of L-shaped rails458 face each other.

Two filters 440 are mounted in recess 457. Each filter 440 is supportedby a filter support member 442. Filter support member 442 has outwardlyextending shoulders 443 that extend from each end of filter supportmember 442. Shoulders 443 are retained by terminal lips 451 of rails458. Filter support member 442 further includes an array of apertures445. Filters 440 cover holes 459. Filter 440 and filter clip 442 aregenerally rectangular in shape.

Filter 440 and filter support member 442 are formed from a flexiblematerial such that filter 440 and filter support member 442 can be bentto allow shoulders 443 to slide under the terminal lips 451.Alternatively, filter 440 can be placed by a user onto filter support442 and the combination is inserted along rails 458. Rails 458 aredimensioned so that as filter 440 and clip 442 are inserted into rails458, filter 440 is compressed or squeezed against the inner surface ofcover 450.

Filter 440 is formed from a microbial barrier material that is permeableto sterilant. Filter 440 allows sterilant to pass from the outside ofcover 450, through holes 459, through filter 440, through apertures 445and into interior cavity 420 where the sterilant contacts surgicalinstruments. Filter 440 also forms a microbial barrier preventingmicroorganisms from entering into container assembly 400 after containerassembly 400 has been processed through a sterilization process.

A locking lid latch 446 is attached to each of end of cover 450. One endof locking lid latch 446 is rotatable attached to each cover end.Locking lid latch 446 can be rotated up and down. When locking lid latch446 is rotated downward and engaged with L-shaped steps 496, the cover450 is removable locked to container 402. Magnets 448 are mounted to aninterior facing surface of locking lid latch 446 and work with halleffect sensor 480 as described later.

An electronic sensor assembly or module 460 is mounted within container402. Electronic sensor module 460 contains electronic components andsensors that measure the characteristics of the environment withincontainer 402 during sterilization processing and determine if requiredconditions have been met to insure sterility of the contents ofcontainer 402.

With reference to FIG. 7A, electronic sensor module 460 has arectangular shaped printed circuit board (PCB) 462. PCB 462 containsprinted circuit lines (not shown) that electrically connect thecomponents of electronic module 460. PCB 462 is mounted above and spacedfrom bottom panel 407 by two or more insulated spacers or standoffs 463.Fasteners 464 such as screws retain PCB 462 and standoffs 463 to bottompanel 407.

Sensors are mounted to PCB 462 to monitor one or more characteristics ofthe environment inside container 402. These sensors including a sensor472 that monitors the concentration of water vapor. This is sometimesreferred to as a humidity or steam sensor. A sensor 473 monitors thefluid (gas) pressure inside the container. A sensor 474 monitors thetemperature within the container. There is also a processor 479 and amemory 471. Also, mounted to the top side of PCB 462 is an opticalsensor 465 that senses the amount of infrared (IR) or ultraviolet (UV)light transmitted through an optical path length 466 within container402. In one embodiment, optical sensor 465 detects concentrations ofhydrogen peroxide gas (H₂O). In another embodiment, optical sensor 465detects concentrations of ethylene oxide gas (C₂H₄O). In anotherembodiment, optical sensor 465 detects concentrations of water or watervapor (H₂O). In another embodiment, optical sensor 465 detects bothhydrogen peroxide vapor (H₂O₂) and water vapor (H₂O).

Optical sensor 465 includes an IR or UV source or emitter 467 and an IRor UV receiver or detector 468 mounted to the top side of PCB 462. Lightfilters (not shown) can be mounted around IR detector 468 and/or lightsource 467 to remove any undesired wavelengths. Because hydrogenperoxide gas absorbs infrared light at a wavelength of 2.93 microns, theamount of light at that frequency transmitted through a known pathlength 466 containing hydrogen peroxide gas is proportional to theconcentration of the hydrogen peroxide gas. Hydrogen peroxide gas alsoabsorbs ultraviolet light at wavelengths near 240 nanometers. Theabsorption of light through a gas is described by the Beer-Lambert law.

Semi-circular light concentrators 469 are mounted to PCB 462. One lightconcentrator 469 is positioned around emitter 467 and another lightconcentrator is positioned around detector 468. Light concentrators 469reflect light rays that are not coaxial to detector 468. An elongatedlight shield 470 is mounted over optical path length 466 and emitter467, detector 468 and both light concentrators 469. Light shield 470 isattached to PCB 462. Light shield 470 prevents stray light rays fromleaving optical sensor 465 and entering interior cavity 420. Lightconcentrators 469 and shield 470 are formed from a material that islight reflective such as polished stainless steel. Light concentrators469 and light shield 470 can work together to reflect emissions fromemitter 467 and concentrate those emissions to increase the energydetected by detector 468.

A battery 497 is mounted to PCB 462 and supplies power to the componentsof electronic module 460. Battery 497 can be formed from one or morebattery cells to form a battery pack depending on the voltage and powerrequirements of electronic sensor module 460. In one embodiment, battery497 is a rechargeable battery. In another embodiment, battery 497 isreplaced with a new battery after being discharged. Light emittingdiodes (LED) 487 such as green, red and yellow LEDS are mounted to PCB462. LEDS 487 provide visual information to personnel using containerassembly 400.

FIG. 7C illustrates additional components contained within window 421.Window 421 in FIG. 7C is formed from a transparent material such asplastic. A hermetically sealed connector 485 is mounted within window421 and contains several terminals 486 that extend through connector 485and are electrically connected to PCB 462. Hermetic connector 485 isconnected with an external connector 475 and cable 476 (FIG. 7A) inorder to transmit and receive data from container assembly 400. LEDS 487on PCB 462 are viewed by a user through window 421. A light shield 477blocks light generated by LEDS 487 from reaching optical sensor 465.

FIG. 7D illustrates another embodiment of components contained withinwindow 421. Window 421 in FIG. 7D is formed from an opaque material suchas plastic. A hermetically sealed connector 485 is mounted within window421 and contains several terminals 486 that extend through connector 865and are electrically connected to PCB 462. Hermetic connector 485 isconnected with an external connector 475 and cable 476 (FIG. 7A) inorder to transmit and receive data from container assembly 400. In theembodiment of FIG. 7D, LEDS 487 are not mounted to PCB 462. LEDS 487 aremounted to the outside of window 421 and are connected to PCB 462 bywires or terminals 478 that extend through window 421. Window 412 issealingly mounted to container wall 406 with a seal, gasket or curablesealing material 422.

Returning to FIG. 7A, a hall effect sensor 480 is mounted to theinterior surface 412 of side wall 406 below rim 413 and another halleffect sensor 480 is mounted to the interior surface 412 of side wall405 below rim 413. Hall effect sensors 480 are connected to PCB 462 bywires 481. When cover 450 is placed over container 402, magnets 448 arejuxtaposed to Hall effect sensors 480. The Hall effect sensors 480 sensethe magnetic field generated by magnets 448 and output an electricalsignal indicating the presence of a detected magnetic field. When latch446 is opened to remove cover 450 from container 402, Hall effectsensors 480 sense the absence of a magnetic field and output anelectrical signal indicating no detected magnetic field. Electronicsensor module 460 can use signals from hall effect sensor 480 to monitorif latches 446 have been properly maintained or tampered with aftersterilization. Alternately, a mechanical item like a one way locking zipstrip (not shown) that prevents locking lid latch 446 from decouplingfrom L-shaped step 496 can serve as a way to visually indicate that thelocking lid latch 446 has been maintained in the correct position. Thesemechanical one way locking zip strips are typically broken and removedso the locking lid latch 446 can be unlatched from L-shaped step 496.

A false bottom plate 490 is mounted over electronic module 460 andbottom panel 407. False bottom plate 490 is rectangular in shape and hasa series of holes 491 extending through plate 490. False bottom plate490 is supported above electronic module 460 by standoffs 492. Standoffs492 rest on bottom panel 407. Fasteners 494 retain plate 490 to bottompanel 407. Fasteners 494 such as screws extend through false bottomplate 490, standoffs 492 and are threaded into bottom panel 407. Holes491 allow sterilant to flow under false bottom plate 490 and intoelectronic sensor module 460. This allows the sensors in the module totake measurements of the characteristics of the environment internal tocontainer 400.

During use, a rack or tray 160 (FIG. 2) containing medical/surgicalinstruments 180 (FIG. 2) in a desired orientation to be sterilized canbe placed within container 402. Rack 160 is placed and rests on plate490. Electronic module and sensors 460 are hidden under plate 490. Aftertray 160 is placed within container 402, cover 450 is placed overcontainer 402 and locking lid latches 496 are moved to the lockedposition, locking and sealing the cover 450 to container 402. Aconnector 475 and cable 476 are attached to connector 485 and memory 471is programmed with validated sterilization process measurement (VSPM).After programming, container assembly 400 is ready for processingthrough a sterilization process cycle.

V. Fourth Container Embodiment

FIG. 8 depicts a container assembly 500 of a fourth embodiment of thepresent invention. Container assembly 500 comprises a container 502 thatis generally rectangular in shape and is defined by a planar front panel503, an opposed planar rear panel 504 and a pair of opposed spaced apartplanar side panels 505 and 506. Panels 503 and 504 are orientedorthogonal to panels 505 and 506. A planar bottom panel 507 is mountedperpendicular to panels 503, 504, 505 and 506 and forms the bottom ofcontainer 502. An interior cavity 520 is defined within container 502.Container 502 has outer surfaces 510 and inner surfaces 512. An upperperipheral rim 513 is defined by the upper edges of panels 503-506.Container 502 can be formed from materials such as stamped aluminum orother suitable materials.

Side panel 506 has a rectangular shaped opening 514 that is covered by apanel 516 that is transparent to visible light but is opaque to IRand/or UV light frequencies. Panel 516 prevents IR and/or UV lightinternal or external to container 502 from passing through panel 516.Transparent panel 516 allows a user to visually see the contents withincontainer 502. An elastomeric gasket 515 seals panel 516 to side panel506. Gasket 515 and panel 516 are attached to side panel 506 using anadhesive or suitable mechanical fasteners (not shown). Anotherrectangular shaped opening 518 is defined in side panel 506 aboveopening 514 and below rim 513. Opening 518 is dimensioned to receive ahermetically sealed switch 521. Several mounting blocks 519 are attachedto the interior surface 512 of panel 506 and extending into cavity 520.Two mounting blocks 519 are positioned below rim 513 and two mountingblocks 519 are positioned at the bottom of panel 506.

A pivoting handle 524 is attached to each of side panels 505 and 506.Handle 524 has ends 525 that are retained on side panels 505 and 506 bycircular shaped bands 526. Two bands 526 are welded to side panel 505and two bands 526 are welded to side panel 506. Ends 525 are received bybands 526 and can rotate within bands 526. Handles 524 pivot between astored position where handles 524 are adjacent side panels 505, 506 anda carrying position where handles 524 extend perpendicular to sidepanels 505, 506.

Cover 550 is used to cover and enclose container 502. Cover 550 includesa generally rectangular shaped panel 552. Cover 550 can be formed frommaterials such as stamped aluminum or other suitable materials. An arrayof holes 559 are defined in and extend through panel 552. Holes 559allow sterilant to enter and leave container 502 during sterilizationprocessing. An outer peripheral flange 553 extends downwardly from theouter edges of panel 552. An inner wall 554 extends downwardly frompanel 552 and is spaced inwardly from flange 553. Flange 553 and flange554 define a U-shaped groove 555 there between. An elastomeric gasket556 is mounted in groove 555. Cover 550 fits over panels 503-506 suchthat rim 513 rests between flanges 553 and wall 554 and is in contactwith gasket 556. Gasket 556 forms a seal between cover 550 and container502. Four generally C-shaped retainer clips 558 extend downward from thebottom surface of panel 552. Clips 558 are positioned toward the centerof panel 552 around the outermost holes 559.

A onetime use or multi-use filter 540 is mounted over holes 559. Filter540 is supported by a filter support member 542. Filter support member542 is retained to panel 552 by retainer clips 558. Filter supportmember 542 is formed from a flexible material such that the ends ofsupport member 542 can be bent under retainer clips 558 in order toretain filter 540 and support member 542 to retainer clips 558. Filter540 covers holes 559. Support member 542 and retainer clips 558 compressfilter 540 against the bottom side of panel 552 over holes 559. Filter540 is formed from a microbial barrier material that is permeable tosterilant. Filter 540 allows sterilant to pass from the outside ofcontainer 502 through holes 559, through filter 540 and into interiorcavity 520 where the sterilant contacts surgical instruments. Filter 540also forms a microbial barrier preventing microorganisms from enteringinto container assembly 500 after container assembly 500 has beenprocessed through a sterilization process.

Container assembly 500 further comprises a lift off hinge 545. Lift offhinge 545 has a C-shaped flange 546 extending away from rim 513 of sidepanel 505 and another C-shaped flange 547 extending away from one end ofcover 550. Flanges 546 and 547 mate with each other to form hinge 545.Flanges 546 and 547 are dimensioned such that when cover 550 is rotatedwith flanges 546 and 547 in engagement with each other toward a closedposition, one end of cover 550 is retained to container 502.

A pivoting latch lock 548 is mounted to the other end of cover 550.Latch lock 548 is rotated by a user downwardly over switch 521 to alocked position where cover 550 is retained to and locked to container502. The movement of latch lock 548 against switch 521 toggles switch521 from an open circuit to a closed circuit. Container assembly 500 isunlocked and opened by a user moving latch lock 548 away from switch 521and rotating cover 550 about hinge 545. The movement of latch lock 548away from switch 521 toggles switch 521 from a closed circuit to an opencircuit.

An electronic sensor assembly or module 560 is mounted within container502. Electronic module 560 contains electronic components and sensorsthat measure the characteristics of the environment within container 502during sterilization processing and determine if required conditionshave been met to insure sterility of the contents of container 502.

Electronic sensor module 560 has a rectangular shaped printed circuitboard (PCB) 562. PCB 562 contains printed circuit lines (not shown) thatelectrically connected the components of electronic sensor module 560.Various electronic components and sensors are mounted to PCB 562 toallow electronic module 560 to monitor the environment inside container502. A processor 570, memory 571 water vapor or steam sensor 572 andisolated temperature sensor 574 are mounted to a top side of PCB 562. Adiaphragm type pressure sensor 573 and/or a capacitance manometer aremounted within interior cavity 520 and is connected to PCB 562 via acable 575.

Also, mounted to PCB 562 is an optical sensor 565 that senses the amountof IR or UV light transmitted through an optical path length 566 withincontainer 502. In one embodiment, optical sensor 565 detectsconcentrations of hydrogen peroxide gas (H₂O₂). In another embodiment,optical sensor 565 detects concentrations of water (H₂O).

Optical sensor 565 includes a light source or emitter 567 and lightreceiver or detector 568 mounted to PCB 562. Light filters (not shown)can be mounted around detector 568 to remove any undesired wavelengths.Semi-circular light concentrators 569 are mounted to PCB 562. Theseconcentrators can have parabolic, elliptical, or other shapes thatconcentrate the light on the photo detector that faces the emitter 567.One light concentrator 569 is positioned around emitter 567 and anotherIR light concentrator is positioned around detector 568.

Replaceable and/or rechargeable batteries 580 are received withinopenings 581 of a battery compartment 582. Battery compartment 582 ismounted to a backside of PCB 562. Batteries 580 supply power to thecomponents of electronic module 560 through printed circuit lines (notshown) within PCB 562. Batteries 580 can be individual cells or packagedtogether into a battery pack arrangement.

Light emitting diodes (LEDS) 584 such as green, red and yellow LEDS aremounted to the top side of PCB 562. A transparent cover 585 is mountedto PCB 562 over LEDS 584. LEDS 584 are viewed by a user through cover585 and window 516. LEDS 584 provide visual information to personnelusing container assembly 500. A connector 594 is mounted to PCB 562 andextends through a bottom portion of battery compartment 582. Connector594 is used to connect to an external connector and cable in order forelectronic sensor module 560 to transmit and receive data orinstructions from external systems and devices.

Battery compartment 582 and a portion of PCB 562 are contained within aninsulative housing 586. Housing 586 is formed from an insulatingmaterial such as plastic. Housing 586 is generally rectangular in shapeincludes an interior chamber 587 and a cover 588. Mounting flanges 589extend perpendicularly away from housing 586 and parallel to side panel506. Battery compartment 582 and a portion of PCB 562 are mounted withinchamber 587. Cover 588 is rotated to a closed position over batterycompartment 582. Switch 521 is also in communication with PCB 562through a wire 588.

Housing 586 is mounted to the interior surface 512 of panel 506. Housing586 is spaced from bottom panel 507 by an insulated spacer or standoff590. Fasteners 591 such as screws extend through mounting flanges 589and are threaded into mounting blocks 519.

During use, a rack or tray 160 (FIG. 2) containing medical/surgicalinstruments 180 (FIG. 2) in a desired orientation to be sterilized areplaced within container 502. Rack 160 is placed onto and rests on bottompanel 507.

An external cable (not shown) is attached to connector 594 in order tostore in memory 571 a validated sterilization process measurement(VSPM). After instruments are placed in container 502, cover 550 isplaced over container 502 engaging hinge 545 and latch lock 548 is movedinto engagement with switch 521 to a locked position, locking the cover550 to container 502. Container assembly 500 is now ready for processingthrough a sterilization process cycle.

VI. Fifth Container Embodiment

Referring to FIG. 9A, a container assembly 600 of a fifth embodiment ofthe present invention is shown. Container assembly 600 includes aversion of container 402. The version of container 402 of FIG. 9A is thesame as the previously described container 402 of FIG. 7A except thatopening 418 is not present. Also magnets 624 are mounted to interiorfacing vertical side surfaces of side panels 405 and 406 slightly belowrim 413.

With additional reference to FIG. 9B, cover 650 is used to cover andenclose container 402. Cover 650 includes a generally rectangular shapedpanel 652. Cover 650 can be formed from materials such as stampedaluminum or other suitable materials. Cover 650 has an inner surface651, an outer surface 654 and opposed ends 653. An array of holes 655are defined in and extend through panel 652. Holes 655 allow sterilantto enter and leave container 402 during sterilization processing. Anouter peripheral wall 656 extends downwardly from the outer edges ofpanel 652. Another rectangular wall 657 extends downwardly from panel652 and is spaced inwardly from wall 656 along the entire length of wall656. Walls 656 and 657 define a U-shaped groove 658 there between. Anelastomeric gasket 659 is mounted in groove 658.

Cover 650 fits over panels 403, 404, 405 and 406 such that rim 413 restsbetween walls 656 and 657 and is in contact with an elastomeric gasket659. Gasket 659 forms a seal between cover 650 and container 402.

Cover 650 further includes an opening 648 defined in one end 653.Opening 648 is dimensioned to receive a window 621. Window 461 istransparent and formed from a plastic material. A hermetic seal 622seals window 621 to end 653. Window 621 and hermetic seal 622 areattached to end 653 using an adhesive.

Side panels 405, 406 further include a pair of opposed L-shaped steps496 that are mounted to opposite ends of container 402. Moreparticularly, steps 496 extend generally perpendicularly away from sidepanels 405, 406 and are angled slightly downwardly with an upwardly arcshape. Steps 496 are used in conjunction with locking lid latch 646,mounted to the cover 650 to secure cover 650 to container 402. Lockinglid latch 646 is rotated by a user downwardly over steps 496 to a lockedposition where cover 650 is retained to and locked to container 402while compressing cover gasket 659 between cover 650 and container 402creating a seal. A locking lid latch 646 is attached to each of end ofcover 650. One end of locking lid latch 646 is rotatable attached toeach cover end. Locking lid latch 646 can be rotated up and down. Whenlocking lid latch 646 is rotated downward and engaged with L-shapedsteps 496, the cover 650 is locked to container 402. Magnets 686 aremounted to an interior facing surface of locking lid latch 646 and workwith hall effect sensor 680 as described later.

A single or multi-use filter 640 is mounted to the bottom surface 651 ofcover 650 over holes 655. Filter 640 is supported by a filter supportmember 642 that extends the length of filter 640. Filter support member642 includes an array of apertures 643 and an opposed pair of shoulders644 that extend away from ends of filter support member 642. A pair ofspaced apart C-shaped clips 645 (FIG. 9B) extend away from bottomsurface 651. When filter 640 and filter support member 642 are mountedto the bottom side 651 of cover 650, a portion of clips 645 extend overshoulders 644 of filter support member 642 thereby retaining filter 640to cover 650. Filter 640 covers holes 655. Filter support holds thefilter 640 to the cover so that all material entering through holes 655must pass through the filter.

Filter 640 and filter support member 642 are formed from a flexiblematerial such that filter 640 and filter support member 642 can be bentto allow shoulders 644 to slide under clips 644. Filter 640 is formedfrom a microbial barrier material that is permeable to sterilant. Filter640 allows sterilant to pass from the outside of cover 650, throughholes 655, through filter 640, apertures 643 and into interior cavity420 where the sterilant contacts surgical instruments. Filter 640 alsoforms a microbial barrier preventing microorganisms from entering intocontainer assembly 600 after container assembly 600 has been processedthrough a sterilization process.

Cover 650 further includes a housing 630. Housing 630 has a generallyrectangular shape with a U-shaped cross section. Housing 630 can beformed from materials such as stamped aluminum or other suitablematerials. Housing 630 comprises a bottom wall 631 and side walls 632.Side walls 632 are spaced apart by bottom wall 631 and are orientedperpendicular to bottom wall 631. Flanges 633 extend perpendicularlyaway from a distal end of each side wall 632. Mounting holes 635 extendthrough flanges 633 at opposite ends of housing 630. Bottom wall 631 andside walls 632 define a cavity or enclosure 638 within housing 630. Anarray of holes 634 are defined in bottom wall 631 and side walls 632.Holes 634 allow sterilant to enter and leave cavity 638. Housing 630 ismounted to the inner surface 651 of panel 652 adjacent end 653 andspaced slightly from wall 657 using fasteners 636 such as screws.Fasteners 636 extend through mounting holes 635 and are threaded intoinner surface 651.

An electronic sensor assembly or module 660 is mounted within housing630 that is retained to cover 650. Electronic sensor module 660 as wellas the below described modules 760 and 850 contains components thatperform the same general functions as module 560.

With reference to FIG. 9A, electronic sensor module 660 has arectangular shaped printed circuit board (PCB) 662. PCB 662 containsprinted circuit lines (not shown) that electrically connect thecomponents of electronic module 660. PCB 662 is mounted and containedwithin housing cavity 638. An insulated spacer 618 is mounted over PCB662 and is located between cover inner surface 651 and PCB 662.

Various electronic components and sensors are mounted to PCB 662 toallow electronic sensor module 660 to monitor operating conditionswithin container 402. A processor 670, memory 671, humidity or steamsensor 672, pressure sensor 673 and isolated temperature sensor 674 aremounted to a top side of PCB 662. Mounted to a bottom side of PCB 662 isan optical sensor 665 that senses the amount of IR and/or UV lighttransmitted through an optical path length 666 within cavity 638. In oneembodiment, optical sensor 665 detects concentrations of hydrogenperoxide gas (H₂O₂).

Optical sensor 665 includes a light source or emitter 667 and a lightreceiver or detector 668 mounted to the bottom side of PCB 662. Lightemitter 667 generates either IR or UV light. Light filters (not shown)can be mounted around emitter 667 or detector 668 to remove anyundesired wavelengths.

A rechargeable battery 697 is mounted to the bottom side of PCB 662 andsupplies power to the components of electronic module 660 throughprinted circuit lines (not shown) within PCB 662. Light emitting diodes(LED) 687 such as green, red and yellow LEDS are mounted to one end ofPCB 662. LEDS 687 provide visual information to personnel usingcontainer assembly 600. LEDS 687 within cover 650 are viewed by a userthrough window 621.

A hermetic connector 685 is mounted within window 621 and extendsbetween the outside of cover 650 to inside cover 650. Hermetic connector685 contains several terminals that are electrically connected to PCB662. Hermetic connector 685 can be connected with an external connector610 and cable 612 in order to transmit and receive data from containerassembly 600. Hermetic connector 685 allows communication withelectronic sensor module 660 when container assembly 600 is in a sealedstate.

With additional reference to FIG. 9B, Hall effect sensors 680 aremounted to an interior portion of wall 657 at each of ends 653. Halleffect sensors 680 are connected to PCB 662 by wires 681. When cover 650is placed over container 402, magnets 624 are juxtaposed to Hall effectsensors 680. The Hall effect sensors 680 sense the magnetic fieldgenerated by magnets 624 and output an electrical signal to processor670 indicating the presence of a detected magnetic field. When cover 650is removed from container 402, Hall effect sensors 680 sense the absenceof a magnetic field and output an electrical signal to processor 670indicating no detected magnetic field.

During use, a rack or tray 160 (FIG. 2) containing medical/surgicalinstruments 180 (FIG. 2) in a desired orientation to be sterilized areplaced within container 402. Rack 160 is placed and rests on bottompanel 407. After tray 160 is placed within container 402, cover 650 isplaced over container 402 and locking lid latches 496 are moved to thelocked position over steps 646, locking the cover 650 to container 402.External connector 610 and cable 612 are attached to hermetic connector685 and memory 671 is loaded with validated sterilization processmeasurement (VSPM). After programming, container assembly 600 is readyfor processing through a sterilization process cycle.

VII. Sixth Container Embodiment

Referring to FIG. 10, a container assembly 700 of a sixth embodiment ofthe present invention is shown. Container assembly 700 comprises acontainer 402. Container 402, filters 440 and cover 450 of FIG. 10 arethe same as the previously described container 402, filters 440 andcover 450 of FIG. 7A except that opening 418 has been omitted fromcontainer 402.

Container assembly 700 includes a rack or tray 720 that contains anelectronic sensor assembly or module 760. Tray 720 can be formed fromsuitable materials such as stainless steel or aluminum. Tray 720comprises a generally planar rectangular shaped base 722 that isperforated with an array of holes 726. Base 722 has an upper surface 723and a bottom surface 724. A peripheral flange 728 extendsperpendicularly downward from the edges of base 722 and encircles base722. Flange 728 and base 722 define a cavity 730 under base 722. Holes726 allow sterilant to enter and leave cavity 730.

Tray 720 is used to hold medical/surgical instruments 180 withincontainer 402 during sterile processing. Tray 720 includes a pair ofspaced apart handles 732 that are mounted to opposite ends of base 722.Handles 732 allow a user to grasp and lift tray 720. Handles 732 includea pair of vertical rods 734 attached to base 722 and a horizontalgrasping bar 736 that extends between rods 734.

Several support members 738 are mounted to and extend upwardly from base722. Medical/surgical instruments 180 rest on and are supported bysupport members 738. Support members 738 are dimensioned and shaped sothat medical/surgical instruments 180 are held and retained in apreferred orientation for sterile processing. It is important for somemedical/surgical instruments 180 to be oriented in certain geometricorientations during sterile processing such that sterilant can readilyenter and exit from the surgical instruments.

A bottom plate 714 is mounted to the bottom surface 724 of base 722enclosing cavity 730. Plate 714 has a top surface 716 and a bottomsurface 718. Four spacers or standoffs 706 are located at the corners ofplate 714. Spacers 706 position plate 714 a fixed distance from base722. Fasteners 708 such as screws extend through the corners of plate714, spacers 706 and are threaded into base 722 thereby retaining plate714 to base 722.

An electronic sensor module 760 is mounted within cavity 730. Morespecifically, module 760 is mounted to the top side 716 of plate 714.

Electronic sensor module 760 has a rectangular shaped printed circuitboard (PCB) 762. PCB 762 contains printed circuit lines (not shown) thatelectrically connect the components of electronic module 760. PCB 762 ismounted to side 716 of plate 714.

Various electronic components and sensors are mounted to PCB 762 toallow electronic module 760 to monitor operating conditions withincontainer 402. A processor 770, memory 771 humidity or steam sensor 772,pressure sensor 773 and isolated temperature sensor 774 are mounted to atop side of PCB 762.

Also, mounted to the top side of PCB 762 is an optical sensor 765 thatsenses the amount of IR and/or UV light transmitted through an opticalpath length 766 within cavity 730. In one embodiment, optical sensor 765detects concentrations of hydrogen peroxide gas (H₂O₂).

Optical sensor 765 includes a light source or emitter 767 and a lightreceiver or detector 768 mounted to the top side of PCB 762. Lightsource 767 generates IR or UV light. Light filters (not shown) can bemounted around detector 768 to remove any undesired wavelengths.

A replaceable or rechargeable battery 797 is mounted to the top side ofPCB 762 and supplies power to the components of electronic module 760through printed circuit lines (not shown) within PCB 762. Light emittingdiodes (LEDS) 787 such as green, red and yellow LEDS are mounted to oneend of PCB 762. LEDS 787 provide visual information to personnel usingcontainer assembly 700. When tray 720 is located within container 402,LEDS 787 are visible by a user through transparent panel 416.

A connector 785 is mounted to the other end of PCB 762. Connector 785can be attached to an external connector 710 and cable 712 in order totransmit and receive data from electronic module 760. Connector 785 isused to load memory 771 with a validated sterilization processmeasurement (VSPM).

Tray 720 is programmed with VSPM. External connector 710 is attached toconnector 785. The VSPM are downloaded to memory 771 from an externalsource. Because each tray 720 is designed to accommodate specificmedical/surgical instruments 180, tray 720 only needs to be programmedwith VSPM once. VSPM are stored within memory 771 for use duringsubsequent sterilization processing cycles.

Tray 720 containing medical/surgical instruments 180 in a desiredorientation to be sterilized are placed within container 402. Tray 720is placed and rests on bottom panel 407. After tray 720 is placed withincontainer 402, cover 450 is placed over container 402 and locking lidlatches 446 are moved to the locked position over steps 496, locking andsealing the cover 450 to container 402.

A lockout tag or breakable seal 792 is attached between locking lidlatch 496 and steps 446. Ends of tag 792 extend through an opening 444in steps 446 and through latch 496 and are mated to form a continuousloop. Tag 792 indicates to a user if any tampering has occurred withincontainer assembly 700 or if the sterile barrier within containerassembly 700 has been compromised after sterile processing. Tag 792 isonly useable once and is cut in order to gain access to the contents ofcontainer assembly 700. After lockout tag 792 is attached, containerassembly 700 is ready for processing through a sterilization processcycle.

VIII. Seventh Container Embodiment

Referring to FIG. 11A, a container assembly 800 of a seventh embodimentof the present invention is shown. Container assembly 800 comprises acontainer 802 that is generally rectangular in shape and is defined by aplanar front panel 803, an opposed planar rear panel 804 and a pair ofopposed spaced apart planar side panels 805 and 806. Panels 803 and 804are oriented orthogonal to panels 805 and 806. A planar bottom panel 807is mounted perpendicular to panels 803, 804, 805 and 806 and forms thebottom of container 802. An interior cavity 820 is defined withincontainer 802. Container 802 has outer surfaces 810 and inner surfaces812. An upper peripheral rim 813 is defined by the upper edges of panels803-806. Container 802 can be formed from materials such as stampedaluminum or other suitable materials.

Side panel 806 has an opening 814 that is covered by a panel 816 that istransparent to visible light but is opaque to IR and UV lightfrequencies. Panel 816 prevents IR and UV light from entering intointerior cavity 820. Transparent panel 816 allows a user to visually seecontents within container 802. An elastomeric gasket 815 seals panel 816to the outside surface of side panel 806. Gasket 815 and panel 816 areattached to side panel 806 using an adhesive.

Container 802 further includes a generally U-shaped cutout 830 that islocated at the bottom of side panel 806 below opening 814. Cutout 830 isdefined by a horizontal shelf 832 that extends perpendicularly from sidepanel 806 into cavity 820 and a U-shaped wall 834 that extendsperpendicularly downward from shelf 832 and terminates at bottom panel807. U-shaped wall 834 has a center section 835 and two diametricallyopposed outer sections 836.

Diametrically opposed windows 837 are defined in each of outer sections836. Windows 837 are separated from each other by a portion of interiorcavity 820. Windows 837 are formed from a transparent material such asplastic and are attached to outer sections 836 by an adhesive.

A hermetic connector 838 is mounted toward the center of center section835. Hermetic connector 838 contains several terminals that extendthrough side panel 838 into interior cavity 820. Hermetic connector 838allows communication with electronic components within container 802. Alatch lock receiver 839 is mounted toward the center of side panel 806below rim 813.

Cover 550 is generally the same as previously described in FIG. 8,except that a magnet 840 has been added to an interior face of pivotinglatch lock 548. Holes 559 allow sterilant to enter and leave container802 during sterilization processing. Gasket 556 forms a seal betweencover 550 and container 802. Disposable filter 540 is mounted over holes559. Filter 540 is supported by a filter support member 542. Filtersupport member is retained to panel 552 by retainer clips 558. Filter540 covers holes 559.

Support member 542 and retainer clips 558 compress filter 540 againstthe bottom side of panel 552 over holes 559. Filter 540 is formed from amicrobial barrier material that is permeable to sterilant. Filter 540allows sterilant to pass from the outside of cover 550 through holes559, through filter 540 and into interior cavity 820 where the sterilantcan contact surgical instruments. Filter 540 also forms a microbialbarrier preventing microorganisms from entering into container assembly800 after container assembly 800 has been processed through asterilization process.

Container assembly 800 further comprises a lift off hinge 545. Lift offhinge 545 has a C-shaped flange 846 extending from rim 813 of side panel805 and another C-shaped flange 547 extending from one end of cover 550.Flanges 846 and 547 mate with each other to form hinge 545. Flanges 846and 547 are dimensioned such that when cover 550 is rotated with flanges846 and 547 in engagement with each other toward a closed position, oneend of cover 550 is retained to container 802.

A pivoting latch lock 548 is mounted to the other end of cover 550.Latch lock 548 can be rotated by a user downwardly to a position wherelatch lock 548 mates with latch lock receiver 839 as shown in FIG. 11C.When latch lock 548 is fully engaged with latch lock receiver 839, cover550 is sealingly locked to container 802. Cover 550 is removed fromcontainer 802 by unlatching latch lock 548 from latch lock receiver 839.

A fixed sensor module 850 is mounted within container 502. Theelectronic components of fixed sensor module 850 use a relatively lowamount of power.

Fixed sensor module 850 has a rectangular shaped printed circuit board(PCB) 852. PCB 852 contains printed circuit lines (not shown) thatelectrically connect the components of electronic sensor module 850. AHall effect sensor 854, processor 870, memory 871, humidity or steamsensor 872, pressure sensor 873 and isolated temperature sensor 874 aremounted to a front side of PCB 852.

A replaceable and/or rechargeable battery 855 is mounted to a rear sideof PCB 852. In one embodiment, because the components mounted to PCB 852consume a relatively small amount of power, battery 855 is watchbattery. Battery 855 supplies power to the components of electronicsensor module 850.

Light emitting diodes (LEDS) 856 such as green, red and yellow LEDS aremounted to the front side of PCB 852. A transparent cover 857 is mountedto PCB 852 over LEDS 856. LEDS 856 within container 802 are viewed by auser through cover 857 and transparent panel 816. LEDS 856 providevisual information to personnel using container assembly 800.

PCB 852 is mounted and contained within an enclosure 860. Enclosure 860is formed from an electrically insulating material such as plastic.Enclosure 860 has two generally rectangular shaped sections, an uppersection 862 and a lower section 863. Upper section 862 defines areceptacle 864 and lower section 863 defines a receptacle 865. PCB 852is mounted to enclosure 860 such that end sections of PCB 852 arecontained within receptacles 864 and 865.

Enclosure 860 with PCB 852 is mounted within interior cavity 820.Enclosure 860 rests on shelf 832 and is attached to the interior surface812 of panel 806. Fasteners 866 such as screws attach enclosure 860 tointerior surface 512. PCB 852 is further attached to and incommunication with hermetic connector 838 via terminals 879 that extendfrom PCB 852 and connect with hermetic connector 838.

A removable optical sensor assembly or module 900 is connectable andremovable from container 502. Removable optical sensor module 900contains electronic components that consume relatively larger amounts ofpower than the electronic components of fixed sensor module 850. Theelectronic components used in removable optical sensor module 900 arealso higher in cost than the electronic components used in fixed sensormodule 850. Removable optical sensor module 900 measures one or morecharacteristics of the environment within container 802 duringsterilization processing.

With reference to FIGS. 11A, 11B and 11C removable optical sensor module900 comprises a generally U-shaped housing 902 and at least one opticalsensor 950. Housing 902 is formed from an electrically insulatingmaterial such as plastic. Housing 902 includes a generally U-shapedouter wall 904 and a U-shaped inner wall 910. A hollow cavity 920 isdefined between outer wall 904 and inner wall 910. Outer wall 904 has acenter section 905 and end sections 906 that extend perpendicularly awayfrom opposite ends of center section 905. A rectangular shaped opening908 is defined toward the top of center section 905.

Inner wall 910 has a center section 912 and end sections 913 that extendperpendicularly away from opposite ends of center section 912. A step914 extends perpendicularly away from a distal end of each end section913. Steps 914 are parallel to center section 912. A rectangular shapedtransparent window 916 is located in each of outer sections 913. Windows916 are diametrically opposed to each other. A connector passage 918 isdefined in center section 912. Connector passage 918 allows a connectorattached to sensor 950 to extend through passage 918. Fasteners 919 suchas screws are used to retain inner wall 910 to outer wall 904.

Optical sensor module 900 is mounted in and received by cutout 830 ofcontainer 802 as shown in FIG. 11C. A retaining clip 924 is mounted inopening 908. When optical sensor module 900 is placed and slid in ahorizontal direction into cutout 830, retaining clip 924 engages andmates with a retaining tab 925 on container 802. Retaining tab 925extends downwardly from the bottom of shelf 832 towards cutout 830.Retaining clip 924 and tab 925 retain optical sensor module 900 tocontainer 802. Optical sensor module 900 is removed from container 802by a user pulling retaining clip 924 away from side panel 806 therebyreleasing retaining clip 924 from engagement with retaining tab 925.Optical sensor module 900 can then be slid in a horizontal directionaway from side panel 806.

Optical sensor 950 is mounted to housing 902 within cavity 920. Opticalsensor 950 is mounted between outer wall 904 and inner wall 910. Opticalsensor 950 senses the amount of IR or UV light transmitted through anoptical path length 966 (FIG. 11B) within container 802. Optical sensor950 detects concentrations of gases such as hydrogen peroxide gas (H₂O₂)or ethylene oxide gas (C₂H₄O).

Optical sensor 950 has a printed circuit board (PCB) 952. An IR and/orUV light source or emitter 967 and a light receiver or detector 968 ismounted to one side of PCB 952. Light filters (not shown) can be mountedaround light source 968 to remove any undesired wavelengths.

A connector 958 is mounted to one side of PCB 952. Connector 958 extendsthrough connector passage 918 (FIG. 11B). Connector 958 mates withconnector 838 of container 802 when housing 902 is inserted into cutout830 and attached to container 802. When attached, connectors 958 and 838allow for communication to occur between optical sensor 950 and fixedsensor module 850. In an optional embodiment, optical sensor 950includes a wireless transceiver that communicates with another wirelesstransceiver within fixed sensor module 850.

A battery 954 is mounted to a second side of PCB 952 to supply power tothe optical sensor 950. Battery 954 is rechargeable through connector958. Signal conditioning and communication devices 956 are also mountedto a second side of PCB 952. Signal conditioning and communicationdevices 956 include logic circuits, amplifiers, filters and input/outputinterfaces to condition and transmit electrical signals between emitter967, receiver 968 and fixed sensor module 850.

When optical sensor module 900 is attached to container 902, lightgenerated by emitter 967 is transmitted through a first window 916, asecond window 837, along optical path length 966 within interior cavity920, through a third window 837, a fourth window 916 and is received bydetector 967. The windows are transparent to the wavelengths/wavelengthsof the photonic energy that is transmitted through the windows.

Detector 967 generates an electrical signal that is proportional to theamount of IR or UV light received which is proportional to theconcentration of sterilant within container 802. The electrical signalis conditioned by signal conditioning and communication devices 956 andtransmitted through connectors 958 and 838 to processor 870 for use indetermining the sterility of the contents of container assembly 800.

During use, a rack or tray 160 (FIG. 2) containing medical/surgicalinstruments 180 (FIG. 2) in a desired orientation to be sterilized areplaced within container 802. Rack 160 is placed onto and rests on bottompanel 807.

An external cable and connector (not shown) are attached to connector838 in order to load memory 871 with validated sterilization processmeasurement (VSPM). After tray 160 is placed within container 802, cover550 is placed over container 802, engaging hinge 545 and latch lock 548is moved into engagement with latch lock receiver 839 to a lockedposition, locking cover 550 to container 802. Container assembly 800 isnow ready for processing through a sterilization cycle.

Removable optical sensor module 900 is attachable and detachable fromcontainer 802 and has several advantages. Because removable opticalsensor module 900 contains higher cost electronic sensor components thatmay consume larger amounts of power, it is desirable to recharge andre-use a relatively small number of removable optical sensor modules 900with a relatively large number of containers 802 that contain fixedsensor modules 850 in order to reduce the overall cost of thesterilization system. Splitting the sterilization sensor electronicsinto two separate assemblies 850 and 950 allows for the use of a lowernumber of removable optical sensor modules.

IX. Electronic Sensor Printed Circuit Boards

FIGS. 12A, 12B and 12C, illustrate further details of the design ofsensor modules, 200, 460, 560, 660 and 760. With specific reference toFIG. 12A, a steam sensing module 1000 is shown. Steam sensing module isspecialized for monitoring and recording steam sterilization processmeasurements. Steam sensing module 1000 comprises a generallyrectangular shaped multi-layer printed circuit board (PCB) 1010 that hasa top side 1012 and a bottom side 1014. Printed circuit lines 1016 arepatterned on each side and layer of PCB 1010 in order to electricallyconnect the components of steam sensing module 1000.

A processor 1020 and memory 1022 are mounted to top side 1012. Ahumidity or water vapor sensor 1024 is mounted to top side 1012.Humidity or water vapor sensor 1024 can be a hygrometer type humiditysensor or a capacitive humidity sensor. Humidity sensor 1024 outputs anelectrical signal (voltage) that is proportional to the concentration ofwater vapor surrounding steam sensing module 1000. In anotherembodiment, water vapor sensor is a optical sensor with an emitter anddetector that operates at a specific wavelength to monitor and read thewater vapor concentration surrounding the optical sensor. Water vaporoptical sensor operation is not described in detail here, but operatesat a different wavelength as the optical sensor 1052 for HydrogenPeroxide vapor as describe later.

Pressure sensor 1026 is mounted to top side 1012. Pressure sensor 1026can be a semi-conductor piezoresistive strain gauge that uses thepiezoresistive effect of bonded or formed strain gauges to detect straindue to applied pressure. Pressure sensor 1026 uses strain gaugesconnected to form a Wheatstone bridge circuit that maximizes theelectrical output and reduces sensitivity to errors. Pressure sensor1026 measures a absolute pressure in atmospheres (atm) or bars. Pressuresensor 1026 outputs an electrical signal (voltage) that is proportionalto the absolute pressure surrounding steam sensing module 1000.

Temperature sensor 1028 is mounted to top side 1012. The structure oftemperature sensor 1028 is not part of the present invention.Temperature sensor 1028 outputs an electrical signal (typically avoltage) that is proportional to the temperature surrounding steamsensor module 1000. Temperature sensor 1028 is mounted and located in anisolated manner such that thermal characteristics of the mounting methodmaximizes the ability of the sensor to measure the temperature of theenvironment with minimal interference from the mount and mountinglocation.

Light emitting diodes (LEDS) 1030 such as green, red and yellow LEDS aremounted to top side 1012. A connector 1032 is mounted to top side 1012.Connector 1032 is used to connect to an external connector and cable inorder for processor 1020 to transmit and receive data from externalsystems and devices. A replaceable and/or rechargeable battery orbattery pack 1034 is mounted to bottom side 1014. Battery 1034 suppliespower to the components of steam sensing module 1000. Processor 1020 andmemory 1022 are in communication with each other. Processor 1020 isfurther in communication with each of sensors 1024, 1026, 1028, LEDS1030, connector 1032 and battery 1034.

Turning to FIG. 12B, a hydrogen peroxide sensing module 1050 is shown.Hydrogen peroxide sensing module 1050 is used when hydrogen peroxide isused to sterilize the instruments. Hydrogen peroxide sensing module 1050contains the same sensors and components previously described for steamsensing module 1000. In addition, hydrogen peroxide sensing module 1050further includes one or more optical sensor 1052 that senses the amountof IR and/or UV light transmitted through an optical path length 1054.

The one or more optical sensor 1052 includes an IR or UV light source oremitter 1056. The emitter 1056 may be a bulb or an LED. Sensor 1052 alsoincludes a detector 1058 capable of output a signal proportional to theintensity of the wavelength of light emitted by emitter 1055. The sensor1052 is mounted to top side 1012. Light filter 1060 is mounted towardsdetector 1058 to remove any undesired wavelengths. Semi-circular lightconcentrators 1062 are mounted to top side 1012. One light concentrator1062 is positioned around emitter 1054 and another light concentrator1062 is positioned around detector 1058. Light concentrators 1062reflect light rays that are not coaxial to detector 1058. Lightconcentrators 1062 are formed from a material that efficiently reflectsemitter 1054 energy towards detector 1058 such as polished stainlesssteel. Processor 1020 is further in communication with emitter 1056 anddetector 1058.

Optical sensor 1052 is configured to detect hydrogen peroxide (H₂O₂)vapor. Because hydrogen peroxide vapor absorbs infrared light at awavelength of 2.93 microns and UV light at a wavelength of 240nanometers, the amount of light transmitted through a known path length(1054) of hydrogen peroxide vapor is proportional to the concentrationof the hydrogen peroxide vapor. A higher concentration of hydrogenperoxide gas results in less light reaching detector 1058. A lowerconcentration of hydrogen peroxide gas results in more light reachingdetector 1058. In one embodiment, optical sensor is capable to measurethe concentration of hydrogen peroxide from 0.05 mg/l up to 25 mg/Lconcentration typically used for sterilization.

The transmittance of light through a gas is described by theBeer-Lambert law. The Beer-Lambert law states that there is alogarithmic dependence between the transmission T, of light through asubstance and the product of the absorption coefficient of thesubstance, a, and the distance the light travels through the material(i.e., the path length), t. The absorption coefficient can, in turn, bewritten as a product of either a molar absorptive (extinctioncoefficient) of the absorber, c, and the molar concentration c ofabsorbing species in the material, or an absorption cross section, a,and the (number) density N of absorbers. For hydrogen peroxide gas,

$T = {\frac{I}{I_{0}} = {e^{{- \alpha^{\prime}}t} = e^{{- \sigma}\;\ell\; N}}}$

where I₀ and I are, respectively, the intensity of the light transmittedin the absence of the light absorbing gas and the transmitted light,respectively; σ is the hydrogen peroxide molar absorption coefficientand N is the hydrogen peroxide concentration. Light detector 1058outputs an electrical signal (voltage) that is proportional to theconcentration of hydrogen peroxide gas surrounding hydrogen peroxidesensing module 1050.

FIG. 12C illustrates another embodiment of a hydrogen peroxide sensingmodule 1080. Hydrogen peroxide sensing module 1080 contains the samesensors and components previously described for hydrogen peroxidesensing module 1050 except light concentrators 1062 have been replacedwith a different type of light concentrator. An oval shaped lightconcentrator assembly 1082 is mounted to the top side 1012 of PCB 1010.

Light concentrator assembly 1082 includes a pair of arc or U-shapedlight concentrators 1084 and a pair of elongated parallel light shields1086. One light concentrator 1084 surrounds emitter 1056 and anotherlight concentrator 1084 surrounds detector 1058. Light shields 1086extend between light concentrators 1084 and are parallel to and spacedapart from light path 1054. An array of holes 1088 are defined in lightshields 1086. Holes 1088 allow hydrogen peroxide gas to circulate alonglight path 1054. Light concentrators 1084 and light shields 1086 areformed from a material that is reflective of emitter energy such aspolished stainless steel. In one embodiment, one sensor module combinessensors and electronic components from both steam sensor module 1000 andhydrogen peroxide sensor module 1050 so that one sensor module can beused to monitor and record in both steam and hydrogen peroxidesterilization processes. When combining steam sensor module and hydrogenperoxide sensor module into one sensor module, all components andsensors from both sensor module 1000 and 1050 can incorporated into onesensor module system as described above or the redundant components canbe eliminated saving cost and reducing the size of the combined sensormodule.

X. Electrical Schematic

Turning to FIG. 13, a block diagram 1100 of an example electronic sensormodule is shown. The schematic of FIG. 13 is intended to illustratefeatures of electronic sensor modules, 200, 460, 560, 660, 760, 1000,1050 and 1080. FIG. 13 will generally be described with reference toelectronic sensor module 1050.

Electronic sensor module 1050 includes a controller 1120. Controller1120 comprises a processor 1020, memory 1022, power monitor 1122 andinput/output interface 1124. Processor 1020 is in communication withmemory 1022, power monitor 1122 and input/output interface 1124 via oneor more communication buses 1126.

Processor 1020 is a suitable microprocessor, field programmable gatearray or an application specific integrated circuit. One or more sets ofinstructions or software are stored on a machine-readable medium ormemory 1022 that embodies any one or more of the methods or functionsdescribed herein. Memory 1022 is a random access memory (RAM) or anonvolatile random access memory such as NAND flash memory or any othersuitable memory. Processor 1020 can also contain memory that at leastpartially stores programs within processor 1020 during executionthereof. Memory 1022 stores software or programs that at least partiallycontrol the operation of container assemblies 90, 300, 400, 500, 600,700 and 800.

The term “memory or machine-readable medium” shall also be taken toinclude any medium that is capable of storing, encoding or carrying outa set of instructions for execution by the processor and that cause theprocessor to perform any one or more of the methodologies shown in thevarious embodiments of the present invention. Machine-readable medium ormemory shall accordingly be taken to include, but not be limited to,solid-state memories, optical and magnetic media, and carrier wavesignals.

Power monitor 1122 regulates and controls the power from power supply1034. Input/output interface 1124 provides the required timing, signallevels and protocols to allow processor 1020 to communicate withcomponents external to controller 1120.

Electronic sensor module 1050 further includes a timer 1132,LEDS/display 1030, power supply 1034, wireless transceiver 1138 and oneor more sensors. Timer 1132 provides clock signals and a real time clockto processor 1020. Timer 1132 may also include additional timeinformation like date and time of day information to processor 1020.LEDS/display 1030 provide visual information to a user. Power supply1034 supplies power to electronic sensor module 1050. Power supply 1034is a battery or other suitable power source.

I/O interface 1124 is in communication with connector 1032 and wirelesstransceiver 1138. Wireless transceiver 1138 includes a wirelesstransmitter and receiver that can transmit and receive wireless signals1140 containing data and instructions between electronic sensor module1050 and other components and devices. In one embodiment, electronicsensor module 1050 is in wireless communication with sterilizationchamber 52 (FIG. 1). In another embodiment, electronic sensor module1050 is in wireless communication with open 359 and close 358 buttons(FIG. 5). In another embodiment, electronic sensor module 1050 is inwireless communication with a docking station as will be describedlater.

Processor 1020 is further in communication with the sensors ofelectronic sensor module 1050 through I/O interface 1124. In oneembodiment, the sensors are mounted within a common enclosure toelectronic sensor module 1050. In another embodiment, the sensors arelocated remote from electronic sensor module 1050 and are incommunication with electronic sensor module 1050 through a signal cableor through wireless communication means.

Humidity or water vapor sensor 1024, pressure sensor 1026, temperaturesensor 1028 and hydrogen peroxide gas sensor 1052 are all incommunication with I/O interface 1124 via one or more communicationbusses 1142. Actuators 312 (FIG. 5), Hall effect sensors 382 (FIG. 5)and switch 521 (FIG. 8) are also in communication with I/O interface1124 via one or more external cables 314 (FIG. 5), 588 (FIG. 8).Processor 1020 via I/O interface 1124 receives data from the sensorsthat indicate environmental characteristics within a containerundergoing sterilization processing.

FIGS. 13 and 14 and the accompanying discussion are intended to providea general description of an exemplary controller or processor adapted toimplement the described embodiments. While embodiments will be describedin the general context of instructions residing on memory stored withina controller, those skilled in the art will recognize that embodimentsmay be implemented in a combination of program modules running in anoperating system. Generally, program modules include routines, programs,components, and data structures, which perform particular tasks orimplement particular abstract data types.

With reference to FIG. 14, details of the contents of memory 1022 areillustrated. Memory 1022 can store a variety of data, sets ofinstructions, software, firmware, programs or utilities for execution byprocessor 1020 and that cause processor 1020 to perform any one or moreof the methods herein described. Memory 1022 comprises validatedsterilization process measurements (VSPM) 1150, sterilizationverification software 1152, sensor calibration software 1154, datarecording software 1155, data 1156 and sterile monitor software 1158.

Validated sterilization process measurements (VSPM) 1150, aremeasurements, minimum values or limits that when met within a container,during a sterilization process, insure sterilization of the equipmentload. Sterilization verification software 1152 uses VSPM 1150 todetermine if the environment within a container meets the VSPMmeasurements, minimum values or VSPM limits.

Sensor calibration software 1154 is used during a sensor calibrationprocess to calibrate the sensors. Sensor calibration software 1154 isused to calibrate or verify accuracy of the sensors prior to the sensorsbeing used to monitor the sterilization process measurements within thecontainer. Sensor calibration can be done in conjunction with thedocking station 1300 in FIG. 16 or sensor calibration software can beused to calibrate the sensors independent of the docking station 1300.

By way of example, sensor calibration software 1154 calibrates thesensors that measure the environmental characteristic by measuring theextent to which a specific wavelength of light is absorbed. One suchsensor is the vaporized hydrogen peroxide sensor. Specifically thiscalibration is performed when chamber is close to a perfect vacuum, forexample approximately 0.2 Torr. At this time there is virtually no gas(vapor) in the chamber. When the chamber, and the container environmentis in this state, there is, by no extension essentially no absorption ofthe emitted light. Data recording software 1155 records the measurement,the signal from the sensor detector when the container is in this stateas the signal level indicating that the container is gas free. Thesubsequent signals representative of the measured gas are compared tothis base signal. Based on this comparison and constants developed basedon the Beer-Lambert law, the concentration of the measured gas iscalculated.

XI. Docking Station

FIG. 15 illustrates one embodiment of a docking station 1200 used inconjunction with container assemblies 90, 300, 400, 500, 600, 700 and800. Docking station 1200 is used during the loading of surgicalinstruments into the containers and to recharge batteries of containerembodiments described herein. With reference to FIG. 15, docking station1200 comprises a frame 1202 and a display 1230. Frame 1202 includes abase 1204 that has four legs 1206 spaced apart from each other by ninetydegrees and a support member 1208. Legs 1206 extend outwardly from thebottom of support member 1208. Wheels 1210 are mounted to the distalends of legs 1206 to allow docking station 1200 to be moved within amedical facility.

A shelf or container holder 1212 is mounted to the upper end of supportmember 1208. A container, for example, container 100 of FIG. 2 rests onand is supported by shelf 1212. Display 1230 is mounted to base 1202 byan articulated arm 1232 that has one or more pivoting joints 1234. Arm1232 can be moved to several different angles and positions by a user bymoving and rotating pivoting joints 1234. Arm 1232 allows display 1230to be positioned for optimal viewing by medical personnel.

Docking station 1200 further includes a handheld reader 1240 andconnector plugs 1250. Handheld reader 1240 is in communication withconnector plugs 1250 via a cable 1242. Handheld reader 1240 can beeither a bar code scanner or an RFID reader. In one embodiment, handheldreader 1240 is a bar code scanner that can scan bar codes 135, 235 (FIG.3) located on container assemblies 90-800. The bar code reader is alsoused to read bar codes on the instrument trays or racks 160 and 720 thatmay be placed in the containers. In another embodiment, handheld reader1240 is an RFID reader that can read RFID tags 135, 235 (FIG. 3) locatedon container assemblies 90-800. Handheld reader 1240 transmits scanneddata to docking station 1200. Handheld reader 1240 is used to obtaindata and information about the containers and/or their contents. Thisread data can be processed by the docking station to provide informationback to the user. For example, the docking station can produce an imageof the equipment set and equipment rack to be loaded into the container.The docking station can provide instructions on what to load, whatorientation to load and how to complete the sterile barrier of thecontainer.

As discussed above, each instrument tray or rack is designed to hold aspecific set of instruments. A set of validated sterilization processmeasurements are known for the particular rack/tray and associatedinstruments. The hand held reader retrieves from the tray or rack thedata identifying the tray or rack Based on these tray or rackidentifying data, the docking station retrieves the VSPM data from thedocking station memory. These data are loaded into the sensor modulememory for the set of instruments to be sterilized. The read data canalso be used with other asset tracking systems and workflow trackingsystems within the hospital to track the location and contents of thecontainer assemblies.

Connector plugs 1250 are mounted to a proximal section of shelf 1212.Connector plugs 1250 are used to connect devices to docking station 1200using cables and connectors. Container 100 with electronic sensor module200 is connected to docking station 1200 through cable 1246. One end ofcable 1246 is connected to connector 244 and the other end of cable 1246is connected to one plug of connector plugs 1250. Cable 1246 is used torecharge batteries of electronic sensor module 200 and to transmit andreceive data between electronic module 200 and docking station 1200. Forexample, validated sterilization process measurements can be transmittedfrom docking station 1200 via cable 1246 and stored in electronic sensormodule 200. In another embodiment, docking station 1200 can communicateby wireless means with electronic sensor module 200.

Display 1230 is in communication with a controller 1402 (FIG. 17) thatis internal to docking station 1230. Display 1230 is a touch screendisplay such as a liquid crystal, LED or plasma display that allows auser to provide input to the docking station. Other input devices suchas a keyboard can be connected to docking station 1200. Controller 1402can show various pictures or screens 1260 on display 1230. For example,in FIG. 15, screen 1260 displays surgical instruments 180 to be placedby a user into tray 160 of container 100. Screen 1260 illustrates to theuser the type of, the name of or number of instruments 180 to be placedon tray 160 and the correct location and orientation of each instrument180 on tray 160. In FIG. 15, the surgical instruments 180 shown arepowered surgical drills or handpieces.

In one embodiment, handheld reader 1240 reads bar codes on surgicalinstruments 180 to be sterilized. Handheld reader transmits the bar codeinformation via cable 1242 to controller 1402. Controller 1402 cansearch a database of tray configurations and display a screen 1260 to auser identifying the correct tray 160 to be used with the identifiedsurgical instruments 180 and the number, location and orientation of theidentified surgical instruments 180 to be placed in tray 160. Thecombination of surgical instruments, instrument rack 160 and other itemsthat were validated together comprise the equipment load inside of thesterile barrier. This equipment load is described in FIG. 19 as contentID 1610. The user can populate the tray 160 with the correct surgicalinstruments 180 in the correct position for sterilization while viewingscreen 1260. Screen 1260 assists in preventing the placement ofincorrect surgical instruments 180 with an incorrect tray 160. Screen1260 also assists in preventing a user from incorrectly orientating thesurgical instruments 180 in tray 160.

Referring to FIG. 16, another embodiment of a docking station 1300 isshown. Docking station 1300 is used in conjunction with containerassemblies 90, 300, 400, 500, 600, 700 and 800. Docking station 1300 isused during the loading of surgical instruments into the containers, tocalibrate sensors and to recharge batteries. Docking station 1300comprises a frame 1302 and a display 1230. Frame 1302 includes agenerally rectangular base 1304 that has four wheels 1306 mounted to thecorners of base 1304.

Panels 1308 cover the sides and rear of frame 1302. A pair of doors 1310are mounted to the front of frame 1302 allowing access to an interiorcompartment 1312 of frame 1302. A rectangular shaped calibration chamber1320 is mounted to the upper half of frame 1302 above doors 1310.Calibration chamber 1320 has a proxil end that extends over doors 1310and a distal end that abuts rear panel 1308. Calibration chamber 1320has interior side, top, bottom and rear panels or walls 1322. Panels1322 define an interior cavity 1324. Calibration chamber 1320 holds acontainer assembly such as container assembly 400 during a calibrationprocess to calibrate the sensors contained within container assembly400.

A door 1326 is mounted to the front of calibration chamber 1320 by ahinge 1328. Door 1326 is moved to open and close calibration chamber1320. Door lock 1330 mates with a lock receptacle 1332 to keep door 1326in a closed position. An elastomeric gasket 1334 is mounted around aperipheral edge of door 1326 and forms a seal when door 1326 is closed.

A connector 1336 is mounted to a side interior wall 1322. Connector 1336is mated with a connector mating portion 1338 and cable 1340 whencontainer assembly 400 is placed in interior cavity 1324. The other endof cable 1340 is connectable to connector 485 mounted to container 402.Connectors 485, 1336, 1338 and cable 485 allow docking station 1300 tocommunicate with electronic sensor module 460 (FIG. 7A) within container402 during a calibration process. While connector 1336 is shown in FIG.16 as being connected to container assembly 400, any of containerassemblies 90, 400, 500, 600 700 and 800 can be connected to connector1336 and calibrated using calibration chamber 1320.

A planar shelf 1342 is mounted over the top of calibration chamber 1320and has an angled portion 1344. A user can place a container on shelf1342. Handheld reader 1240 is stored in a holder 1345 in angled portion1344 when not in use.

Several charging receptacles 1346 are mounted to angled portion 1344.Charging receptacles 1346 are shaped to receive electronic sensormodules 200 (FIG. 1) that have been removed from their respectivecontainer in order to recharge batteries within electronic sensor module200. Charging receptacles 1346 are also able to receive removablebattery packs such as batteries 1034 (FIG. 12B) for recharging. Chargingreceptacles 1346 contain terminals (not shown) that are connected to abattery charger internal to docking station 1300.

Display 1230 is mounted to frame 1302 by an articulated arm 1232 thathas one or more pivoting joints 1234. Arm 1232 is moved to severaldifferent angles and positions by a user by moving and rotating pivotingjoints 1234. Arm 1232 allows display 1230 to be positioned for optimalviewing by medical personnel. Display 1230 can show screens 1260 aspreviously described in conjunction with FIG. 15.

Turning now to FIG. 17, an electrical block diagram 1400 of dockingstations 1200 and/or 1300 is depicted. A docking station controller 1402controls the operation of docking stations 1200 and 1300. Dockingstation controller 1402 comprises a processor 1410, memory 1412 andinput/output interface 1414. Processor 1410 is in communication withmemory 1412 and input/output (I/O) interface 1414 through one or morecommunication buses 1416. The components of controller 1402 are mountedto a printed circuit board (not shown).

Processor 1410 is a suitable microprocessor, field programmable gatearray or an application specific integrated circuit. One or more sets ofinstructions or software are stored on a machine-readable medium ormemory 1412 that embodies any one or more of the methods or functionsdescribed herein. Memory 1412 is a random access memory (RAM) or anonvolatile random access memory such as NAND flash memory or any othersuitable memory. Processor 1410 can also contain memory that leastpartially stores programs within processor 1410 during executionthereof. Memory 1412 stores software or programs that control theoperation of docking stations 1200 and 1300.

Power supply 1418 supplies power to the components of controller 1402and other components of docking stations 1200 and 1300. Power supply1418 is connected to a utility power source. I/O interface 1414 providesthe required timing, signal levels and protocols to communicate withcomponents internal and external to controller 1402.

I/O interface 1414 is in communication with battery charger 1420 andwireless transceiver 1422. Battery charger 1420 is used to recharge thebatteries contained within the electronic sensor modules connected tothe docking station. Wireless transceiver 1422 includes a wirelesstransmitter and receiver that can transmit and receive data andinstructions via a wireless signal 1424. In one embodiment, dockingstations 1200 and/or 1300 communicate with container assemblies 90-800using wireless signal 1424.

I/O interface 1414 is also in communication with other externalcomponents such as a keyboard 1426, display 1230 and handheld reader1240. Keyboard 1426 is used to input information to docking stations1200 and 1300. Processor 1410 transmits video display data such asscreens 1260 to be shown on display 1230. Handheld reader 1240 transmitsdata to processor 1410.

I/O interface 1414 is further in communication with several componentsused during a calibration procedure with docking station 1300. I/Ointerface is in communication with a steam generator 1430, hydrogenperoxide generator 1432, pressure pump 1434, vacuum pump 1436 and heater1438 via communication bus 1416. All of the calibration components aremounted within interior compartment 1312 (FIG. 16) below calibrationchamber 1320 (FIG. 16).

Steam generator 1430 is connected by piping to calibration chamber 1320.Steam generator 1430 is used to generate a known concentration of steamwithin calibration chamber 1320 during a calibration procedure. Hydrogenperoxide generator 1432 is connected by piping to calibration chamber1320. Hydrogen peroxide generator 1432 is used to generate a knownconcentration of hydrogen peroxide within calibration chamber 1320during a calibration procedure. Pressure pump 1434 is connected bypiping to calibration chamber 1320. Pressure pump 1434 is used togenerate a known pressure level within calibration chamber 1320 during acalibration procedure.

Vacuum pump 1436 is connected by piping to calibration chamber 1320.Vacuum pump 1436 is used to generate a known vacuum level withincalibration chamber 1320 during a calibration procedure. Heaters 1438are mounted to the outer surfaces of interior walls 1322 (FIG. 16) ofcalibration chamber 1320. Heaters 1438 are used to generate a knowntemperature within calibration chamber 1320 during a calibrationprocedure. Processor 1410 controls the operation of steam generator1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump1436 and heater 1438 during a calibration procedure.

Processor 1410 is in communication with a network 1450 via a networkcommunication fabric 1452. In one embodiment, network 1450 is incommunication with a medical facility or hospital data processing systemor computer system 1454 via network communication fabric 1458. Dockingstations 1200 and 1300 can transmit and receive information fromcomputer system 1454. For example, hospital computer system 1454 canmaintain a database 1456 of surgical instruments and tools used withinthe medical facility. Docking stations 1200 and 1300 can transmitinformation regarding the number and type of sterile or non-sterilesurgical instruments contained in a container to hospital computersystem 1454 in order to update database 1456. Data transmitted andreceived between the various computer systems and data sources may beencrypted for security purposes to prevent unauthorized access ortampering.

Memory 1412 can store a variety of data, sets of instructions, software,programs or utilities for execution by processor 1410 and that causeprocessor 1410 to perform any one or more of the methods hereindescribed. Items stored in memory 1412 may be encrypted prior to storagefor security purposes.

Memory 1412 comprises nominal chamber processing parameters (CPP) 66,sensor calibration software 1460, container programming software 1461,container loading software 1464, container configuration data 1465,equipment load data, validated sterilization process measurements (VSPM)1150, process measurement limit determination software 1466, usage data1470 and usage software 1472.

CPP 66 are the nominal processing settings used by health care workersto program CPP 66 to the nominal sterilization process for sterilizationchamber 52 to control the sterilization process cycle. Sensorcalibration software 1460 is used by docking station 1300 during thecalibration of the sensors associated with a respective container.Sensor calibration software 1460 at least partially controls theoperation of steam generator 1430, hydrogen peroxide generator 1432,pressure pump 1434, vacuum pump 1436 and heater 1438 during acalibration procedure.

Container programming software 1461 is used to load container memory1022 with VSPM 1150. Container loading software 1464 is used withcontainer/tray configuration data 1465 to verify that the correctsurgical instruments are loaded into the proper tray and container.

VSPM 1150 are the values of sterilization process measurementsassociated with an equipment load, that when met within a container foran equipment load, insure sterilization of the container contents.Container and tray configurations 1464 are a database of containertypes, tray and rack types if needed and surgical instruments thatdetail the tray to be used with specific surgical instruments and theplacement and orientation of the surgical instruments within the tray.VSPM 1150 is correlated to the surgical equipment load using methodsdescribed herein. Container loading software extracts the surgicalequipment load configuration to aid the health care worker when they areloading and preparing a container for sterilization. Container loadingsoftware can also facilitate data inputs to record who is preparing thecontainer, when they are preparing the container, what is loaden to thecontainer and other pertinent information that are required byregulations or are good business practices for recording, tracking orimproving the quality of the container loading process. The containerand tray configurations data can be written text, images of instrumentracks, instrument configurations and/or instrument orientations or acombination of both text and images.

Process measurement limit determination software 1466 is used todetermine and generate the values for VSPM 1150 data. Typically, processmeasurement limit determination software 1466 will be used by the OEM ofthe instrument set to establish and correlate VSPM data of the equipmentcombination to the sterilization validation. Hospitals or users of theVSPM data would not typically use process measurements limitdetermination software 1466. Hospitals could use the processmeasurements limit determination software 1466 if they want to validateand correlate a surgical equipment load that is different than what wasprovided by the OEM. Usage data 1470 contains data tracking the numberof sterilization processing cycles undergone by each of the respectivecontainers or tracks the number of hours that each of the respectivecontainers are in use. Usage software 1472 is a software program thatmonitors the number of sterilization processing cycles undergone by eachof the respective containers or tracks the number of hours that each ofthe respective containers are in use and generates usage data 1470.Usage data can be used for billing, sterile processing or workflowstatus, calibration status or for preventative maintenance of electronicsensor modules or containers.

In some versions of the invention the hand held reader is used toidentify which specific instruments are placed in a container. After asterilization cycle, the sterilization process measurements recorded bythe sensor module for the container is matched with the data identifyingthe instruments in the container. Thus a log is maintained for eachinstrument of the number of sterilization processes to which theinstrument was exposed and the environmental measurements made duringthe process. These data may also be used for inventory and billingcontrol.

XII. Computerized Method of Tracking Container Usage and Billing on FeePer Use Basis

With reference to FIG. 18, a diagrammatic view of a networked computersystem 1500 for tracking container usage and billing is shown. Networkedcomputer system 1500 comprises one of docking stations 1200, 1300, amanufacturer computer system 1510 and a hospital computer system 1454that are all interconnected by a communication network 1450 and incommunication with each other. Communication network 1450 can encompassa variety of networks such as the internet, local area networks, widearea networks or wireless communication networks.

Manufacturer computer system 1510 and hospital computer system 1454include any type of computing device or machine that is capable ofreceiving, storing and running a software product including not onlycomputer systems and servers, but also devices such as routers andswitches, mainframe computers and terminals. The operation ofmanufacturer computer system 1510 and hospital computer system 1454 willbe described in the general context of instructions residing on hardwarewithin a server computer. Those skilled in the art will recognize thatembodiments may be implemented in a combination of program modulesrunning in an operating system. Program modules include software,routines, programs, components, and data structures, which performparticular tasks or implement particular data types. The invention mayalso be practiced in distributed computing environments where tasks areperformed by remote processing devices that are linked through acommunications network. In a distributed computing environment, softwareprogram modules may be located in both local and remote memory storagedevices.

Manufacturer computer system 1510 is in communication with network 1450via communication fabric 1552. Manufacturer computer system 1510includes a processor 1520 and memory 1522. Memory 1512 can store avariety of data, sets of instructions, software, programs or utilitiesfor execution by processor 1520. Memory 1522 comprises invoice software1530, invoices 1532 and usage data 1472. Usage data 1472 can includehospital account information like hospital name, account number, billinginterval, contract pricing and other pertinent information to properlytrack equipment usage and billing.

Docking station 1200, 1300 transmits usage data 1472 to manufacturercomputer system 1510. Invoice software 1530 when executed by processor1520 generates invoices 1532 based on usage data 1472 received fromdocking station 1200, 1300. Processor 1520 stores the invoices in memory1532 and transmits the invoices 1532 to hospital computer system 1454.

Hospital computer system 1510 is in communication with network 1450 viacommunication fabric 1458. Hospital computer system 1454 includes aprocessor 1570 and memory 1572. Memory 1572 can store a variety of data,sets of instructions, software, programs or utilities for execution byprocessor 1570. Memory 1572 comprises invoices 1532 received frommanufacturer computer system 1510 and database 1456.

Networked computer system 1500 is used in conjunction with a businessmodel where docking stations 1200, 1300 and containers 90-800 are leasedor rented to a medical facility or hospital. The medical facility orhospital pays for using the docking stations and containers on a fee peruse basis. In one embodiment, docking station 1200, 1300 tracks thefrequency of use of containers 90-800 during sterilization processingand generates usage data 1472 that is transmitted to manufacturercomputer system 1510. Manufacturer computer system 1510 generatesinvoices 1532 based on the amount of use of containers 90-800 andtransmits the invoices to hospital computer system 1454 where theinvoices are processed for payment.

XIII. Validated Sterilization Process Measurements (VSPM)

FIGS. 19A-1 and 19A-2 when placed side-to-side form a table of validatedsterilization process measurements (VSPM) 1150. VSPM 1150 are stored inmemory 1412, memory 1522 or memory 1572 (FIG. 17). In some embodimentsVSPM 1150 are stored in sensor module memory 1022. VSPM 1150 data inother embodiments are stored in memory 1412, or memory 1522 or memory1572 in a secure manner so that the correlated or associated VSPM datais not modified after the validation and correlation process describedherein. VSPM 1150 data are determined during a validation andcorrelation process as described in detail later. Generally, thevalidation and correlation process is used to correlate or associatesterilization process measurements, as measured by sensors withincontainers during the sterilization validation process to a desiredmicroorganism killing result for a given set of surgical equipment orequipment load. The data measured and recorded by the electronic sensorsystem during the validation is then used to establish VSPMmeasurements, thresholds or VSPM limits data sets. After the VSPM datasets are validated and correlated, these VSPM data sets are used tocompare sterilization process measurements at health care facilities, asmonitored by sensors within container assemblies, to determine if theprocess measurements for the equipment load meet, exceed or are withinthe VSPM data set. This comparison method is considered a verificationmethod that can be used with suitable sensor systems and containerassemblies each time Healthcare personnel sterilize surgical equipmentloads or sets using the methods and systems described herein. The VSPMdata in one embodiment are time based sterilization process measurementsor limits that, based on the validation and correlation method, thatwhen achieved during a sterilization processes for the associated set ofsurgical equipment, confirm that the sterilization process measurementswere verified thus assuring the same results achieved during thevalidation process, namely the same level of sterilization ordisinfection of the equipment load. VSPM 1150 include one or more datasets (VSPM 1150-Steam1, VSPM-1150-HPV) associated with contentidentifier (ID) 1610. Content identifier 1610 identifies the surgicalequipment load inside the sterile barrier or container. Content ID 1610describes the surgical instruments, surgical tools 180 (FIG. 2), andinstrument racks 160, 720 within the container or sterile barrier, oftencalled the surgical equipment load, that are correlated or associatedwith validated sterilization process measurements (VSPM) data sets. Forexample content CID 1160-3 can identify a Stryker batteries surgicalequipment load consisting of rechargeable batteries for rotary surgicalhandpieces 180. CID 1160-3 can be written, electronic or both types oftext, images or photographs that describe the composition of theequipment load associated with VSPM data. For example, contentidentifier can include surgical equipment types, part numbers, serialnumbers, quantities and other unique equipment load identifiers thatwere validated together during a sterilization validation andcorrelation process. In one embodiment, content identifier 1610 can beelectronic photographs taken of the equipment load during thesterilization validation process using methods in FIGS. 22-24. Inanother embodiment, content identifier 1610 may include a listing of thetray or rack identifier model number for instrument rack (160, 720) thatwas used during a sterilization validation process as well as a listingof all of the equipment contained therein. For example equipment contentidentifier CID-1610-1 includes the instruments and utensils 180-1 listedin FIG. 19(a) and the instrument rack (160, 720) identified as Stryker7102-450-010. For Tray or rack 720 identification is important becauseit orients the cannulas within the rotary surgical handpieces in agenerally downward orientation to facilitate air removal and waterdrainage thereby facilitating sterilization.

VSPM 1150 further includes one or more data sets of validatedsterilization process measurements, when one or more sterilizationprocess validations were performed and associated with a contentidentifier 1610 or equipment load. For example one data set(VSPM-1150-S-1) for a validated steam sterilization process, can containwater vapor measurements, temperature measurements and time limit andabsolute pressure measurements and time limit for a content identifierCID 1610-1. In another embodiment, another data set (VSPM-1150-H-1) fora Hydrogen Peroxide sterilization process can consist of temperaturelimits, pressure limits, water vapor concentration and the area underthe time based hydrogen peroxide vapor concentration curve associatedwith the same content identifier CID_1160-1. For steam sterilization,the temperature is the threshold or minimum temperature held for aminimum period of time that the interior environment and instrument loadwithin container assemblies 90-4600 are required to experience during asterilization process in order to insure VSPM data measurements are met.For example, the validated sterilization process measurements forcontainer No 7102-450-040 when rack No. 7102-450-010 is contained in thefirst row of the table of FIGS. 19A-1 and 19A-2. More particularly thesedata are the VSPM data for when the rack and the instruments disposed onthe rack (collectively the load) are subjected to a steam sterilizationprocess. AS specified by the table cell the instruments on the rackconsidered to be sterilized if the interior of the container issubjected to saturated steam at a minimum temperature of 270° F. andthat temperature is maintained for at least 3 minutes 55 seconds.

The temperature of saturated steam can be calculated from the pressuremeasurements and compared against the temperature measurements to verifythat the steam is saturated. This comparison of the measured steamtemperature to the calculated saturation temperature can also be used toverify that air is not present in sufficient quantity to adverselyaffect sterilization efficacy.

The validated sterilization process measurements data 1150 may havethresholds or limits that the individual measurements mustsimultaneously stay within as a function of time or across the same timeinterval. For the example just provided, the temperature, absolutepressure and saturation level of steam may have limits established forthe 3 minute 55 second time period. Alternately, these measured processmeasurements may have specific limits that vary as a function of time.For example, the first 2 minutes of a steam sterilization cycle, thetemperature may have a minimum threshold of 131° C. and above and forthe next 2 minutes the temperature may have a different threshold of133° C. and above. When the instrument set is designed and validated formore than one type of sterilization cycle, the VSPM can include morethan one type of VSPM data set. If the OEM designs and validates itsequipment to be sterilized with both steam and hydrogen peroxidesterilization process, the VSPM table contains VSPM data for bothsterilization process. In the table of FIGS. 19A-1 and 19A-2, the VSPMdata for the separate sterilization processes are shown in separatecolumns. In this table, the VSPM measurements for a steam sterilizationprocess is shown in the first row. Row two contains the VSPM data forthe same load if the instruments are to be subjected to a vaporizedhydrogen peroxide sterilization process. The table has both VSPM datasets, one set of data for steam sterilization (VSPM-1150-S-1) and oneset of data for hydrogen peroxide sterilization (VSPM-1150-H-2) with thesame content CID 1610-1. More specifically, content CID 1610-1 can beassociated with Temperature, absolute pressure and steam saturation VSPM1150-S-1 data set for steam sterilization and Temperature, absolutepressure, hydrogen peroxide concentration and water concentration VSPM1150-H-1 data set for hydrogen peroxide sterilization. This provides thecapability for the VSPM data sets to be added for a given equipment loador content ID to include additional VSPM data for specific sterilizationmodalities after they have been validated and correlated as describedherein. The sensor modules can be designed for use in a singlesterilization modality and denoted by SM0000XS for steam or SM0000XH forhydrogen peroxide where 0000X identifies the type of sensor module. Inanother embodiment, the sensor modules can also be designed for use inmore than one sterilization modality. For example sensor module denotedby SM0000XSH can be used in both steam sterilization and hydrogenperoxide sterilization modalities where 0000X is the serial numberassigned to the sensor module. FIG. 19 is arranged with a unique sensormodule in a row. A sensor module could be used with any compatibleContent ID 1610. For example, Stryker Sensor Module SM00001S could beused with Content Identification CID 1610-1, CID 1610-2 or CID 1610-5.

For some sterilization processes, the validated sterilization processmeasurements are measurements that are generated over time. In thesimplest form, these measurements are measurements that indicate theenvironment inside the container had a minimal concentration of aparticular sterilant for a defined minimum period of time. One simpleexample are a set of measurements that indicate the containerenvironment contained saturated steam for a period of at least 5minutes.

A more complex set of measurements are used to generate the area under acurve. The X-axis against which this curve is plotted is time; theY-axis is the concentration of the sterilant. Typically the time is inseconds and the concentration mg/l. Thus for one set of instruments in acontainer the validated sterilization process may be a process where thearea under this curve is a vaporized hydrogen peroxide concentration of5000 (mg/l) (sec.) This means that for a first sterilization cycle thevalidated sterilization process measurements are satisfied if aconcentration of 25 mg/l of vaporized hydrogen peroxide is measured forat least 200 seconds. For a second sterilization cycle the validatedsterilization process measurements are satisfied if a concentration of20 mg/l of vaporized hydrogen peroxide is measured for at least 100second. It should of course further be appreciated that the area underthis curve is typically for a minimal concentration of sterilant. Thus,in the example above, time periods in which the container environmenthas a concentration of vaporized hydrogen peroxide less than 18 mg/l arenot integrated into the targeted measurement.

The area under the time based hydrogen peroxide concentration curve isthe threshold or minimum (mg/liter)(sec) of hydrogen peroxide to whichthe interior of one of the containers is exposed to insure that thecontents of the container are sterilized. For example, the interior ofcontainer Stryker 7102-450-040 is required to be exposed to a minimum of2500 mg-s/l of hydrogen peroxide during a sterilization process cyclewhen equipment of content ID CID 1610-1 is present as set forth in theline 2 of FIG. 19A. If the water vapor content is low compared to whatit could have been at 100% saturation at any time during the exposure,the effective concentration can be reduced at that time when it is addedinto the area under the time based concentration curve. For example, theeffective concentration can be halved when the concentration of watervapor is less than 80% of the saturation concentration. The saturationconcentration of water vapor depends upon both vapor temperature and theconcentration of hydrogen peroxide vapor that is present.

Additional information in other embodiments described in FIG. 19A may beoptionally associated with either CID 1610 or VSPM 1150 data sets orboth. For example, Container ID 1605 identifies and describes thespecific type of container 90-4600 that was previously subjected to asterilization validation process. When the sterilization process resultsare known to or are suspected to be affected by the type of container orthe type of sterile barrier used for an equipment load, container ID maybe associated with either content ID or VSPM data sets or both. If thetype of container or sterile barrier used during a sterilization processis known to not affect sterilization results, container ID may not beassociated with content ID or VSPM data sets. The later embodimentallows the sterile barrier or container type used for sterilization athealth care facilities to change for an equipment load without changingthe sterilization results as long as the process measurements areproperly verified to comply with VSPM 1150 using sensor modules andmethods described herein. For example, a container identified identifiesa specific container serial number provided by an OEM or within themedical facility. The container ID can identify and translate to thecontainer type, sterile barrier used, the electronic sensor module 200,460, 560, 660, 760, 1000, 1050, 1080 type or sensor moduleconfiguration. Other data associated with content ID 1610 or VSPM 1150data or both listed in FIG. 19 can be useful, but not necessary whenusing different embodiments of this invention. For example, Nominalprocess parameters can be output by the docking station so thesterilizer operator can set the nominal process parameters forprogramming the sterilizer. These nominal process parameters in thisexample would be greater than or equal to the nominal process parametersused during the validation and correlation of VSPM 1150 data to contentID 1610. In other embodiments, data table may further include sensormodule usage. The total number of sterilization cycles can be obtainedfrom the sensor module usage data and can be used for business purposeslike automated invoicing, preventative maintenance and for periodicreplacement of container and sensor components. The dates, contentidentifiers, container identifiers for the sterilized loads are used bythe central processing department for inventory tracking, billing andcontrol purposes.

During loading and programming of a container using a docking station,at least a portion of VSPM 1150 are transmitted from the docking stationto the electronic sensor module and are stored in module memory 1022(FIG. 14). For example, if the container is being loaded and programmedwith content ID 1610-1 and tray ID Stryker 7102-450-010, only the VSPM1150-S-1 associated with content ID 1610-1 and associated sterilizationprocess are transmitted from memory 1412 to memory 1022.

XIV. Automatic Closing Container Vent

FIGS. 20A-20C illustrate a container assembly 1700 having an automaticclosing lip cap assembly 1720 that is mounted to a container cover 1710.Container assembly 1700 can retrofit an existing sterilization containerinto a container that automatically closes after receiving a closingsignal from an electronic sensor module. Automatic closing containervent, when positioned in an open state during a sterilization process,allows unrestricted passage of sterilization agents into the containerproviding easier access to the contents of the container to affectsterilization.

Container assembly 1700 is employed when the efficiency of thesterilizing process is reduced or rendered ineffective as a result ofthe presence of a filter over the through openings in the container. Onereason a filter may have this affect on the sterilizing process isbecause owing to the composition of the filter and the composition ofthe sterilant, the presence of the filter inhibits the flow of sterilantthrough the filter. The presence of a filter may adversely also affectsterilization is because, the sterilant when exposed to the materialforming the filter, undergoes a chemical reaction that reduces theefficacy of the sterilant.

Thus, to avoid these undesirable effects of the presence of a filtercontainer assembly 1700 typically does not include a filter. The vent isopen and flow through the vent is unrestricted at least for the timeperiod the container and the contents therein are undergoing asterilization cycle.

Container cover 1710 is generally similar to cover 450 of FIG. 7A;however cover 1710 does not have any holes 459 or filter assemblies 440.Cover 1710 has a planar top panel 1712. Top panel 1712 has an uppersurface 1714 and a bottom surface 1716. A circular central opening 1718is defined in top panel 1712. Cover 1710 is placed over container 402 inorder to enclose container 402.

Container cover 1710 and container vent assembly 1720 can be retrofittedto any the previously described containers 100, 402, 502 and 802 inorder to provide the containers with a cover that automatically closesafter the completion of a sterilization process cycle. While containervent assembly 1720 is shown mounted to cover 1710, container ventassembly 1720 alternatively can be mounted to any of the side panels ofcontainer 402. By relocation the container vent to a different panel itmay allow steriliant to enter and exit more efficiently to affectsterilization of the contents of the container. Also, more than onecontainer vent 1720 positioned on one or more panels may be used on asingle container.

Automatic closing container vent assembly 1720 is mounted to top panel1712. More specifically, container vent assembly 1720 is received byopening 1718. Container vent assembly 1720 comprises a circular carriage1722, cap 1760, circuit board 1770 and linear solenoid 1780. Carriage1722 includes an outer ring 1728 connected to a central drum 1734 bycross members 1724. Outer ring 1728 is perpendicular to cross members1724. A peripheral rim 1726 extends perpendicularly away from andsurrounds ring 1728. A recess 1730 is defined between ring 1728 andcross members 1724. Carriage 1722 and container vent 1760 are formedfrom injection molded plastic.

Carriage 1722 is mounted in opening 1718. Rim 1726 rests on top surface1714 supporting carriage 1722. The outer surface of ring 1728 abuts theannular portion of panel 1712 defined by opening 1718. In oneembodiment, carriage 1722 is press fit into opening 1718. In anotherembodiment, carriage 1722 is sealingly affixed to panel 1712 using anadhesive or sealed mechanical fasteners.

Central drum 1734 is cylindrical in shape and has a base 1736. An outerwall 1738 and an inner hub 1740 extend perpendicularly away from base1736. Base 1736, outer wall 1738 and inner hub 1740 define a groove 1742therein. A central bore 1744 extends entirely through base 1736 andinner hub 1740. Another bore 1746 extends perpendicularly through innerhub 1740 approximately midway along the length of inner hub 1740. Bore1746 extends between groove 1742 and bore 1744. Several mounting bosses1748 are affixed to base 1736 adjacent wall 1738. Mounting bosses 1748extend perpendicularly away from base 1736 into groove 1742. Mountingbosses 1748 are used to attach circuit board 1770 to carriage 1722.

Cap 1760 includes a circular disc 1761 that is attached to a cylindricalshaft 1765. Disc 1761 has an outer annular side 1762. An annular groove1763 is defined in side 1762. Groove 1763 is dimensioned to receive acircular elastomeric O-ring 1764. Cylindrical shaft 1765 extendsperpendicularly away from the bottom side of disc 1761. Shaft 1765 has acentral bore 1766 that extends partially into shaft 1765 parallel to theaxis of shaft 1765. Shaft 1765 also has two bores 1767 and 1768 thatextend partially into shaft 1765 perpendicular to the axis of shaft1765. Bores 1767 and 1768 have a length that is approximately one halfthe diameter of shaft 1765. Bore 1767 is spaced from the bottom side ofdisc 1761 and bore 1768 is spaced from the terminal end of central bore1766.

A printed circuit board 1770 is affixed in groove 1742 by fasteners1771. Groove 1742 is dimensioned to receive printed circuit board 1770.Fasteners 1771 extend through circuit board 1770 and are threaded intomounting bosses 1748. Several electrical components are mounted tocircuit board 1770. A battery 1772, wireless transceiver 1773, solenoidhousing 1774 and solenoid driver 1775 are mounted to circuit board 1770.Linear solenoid 1780 is mounted in and held by solenoid housing 1774.Battery 1772 is either a rechargeable or replaceable battery or suppliespower to the components of circuit board 1770. Printed circuit board1770 is in communication with one of electronic sensor modules 200, 460,560, 660, 760 and 850. In one embodiment, wireless transceiver 1773receives wireless communications from one of the electronic sensormodules 200-850. In another embodiment, an electrical cable 1779 isconnected between circuit board 1770 and one of the electronic sensormodules 200-850. Solenoid driver 1775 is in communication with linearsolenoid 1780 and causes linear solenoid 1780 to move an attached rod1782. Rod 1782 is linearly movable between an extended position and aretracted position.

A coil spring 1790 surrounds shaft 1765. A spring retainer 1792 ismounted over coil spring 1790 and includes a boss 1793 that extends intobore 1766. Spring retainer 1792 retains coil spring 1790 to shaft 1765.Spring retainer 1792 has an annular lip 1794 that extends over and abutsa distal end of spring 1790. The proximal end of spring 1790 abuts theterminal end of inner hub 1740. Spring retainer 1792 is either press fitinto bore 1766 or is affixed in bore 1766 using an adhesive. Coil spring1790 biases container vent 1760 to move towards carriage 1722. In anopen position, as shown in FIG. 20B, a passage 1996 is formed betweencarriage 1722 and the bottom of disc 1761.

Container vent 1760 is retained in the open position, by solenoid rod1782 extending through inner hub bore 1746 and into container vent bore1768. In this position, coil spring 1790 is compressed. Container vent1760 is opened from a closed position in a two step process. First, auser uses an input device to trigger the retraction of solenoid rod 1782out of bore 1767 by solenoid 1780. In one embodiment, the input deviceis the touch screen 1230 (FIG. 15) of docking station 1200. Second, theuser manually grasps container vent 1760 and pulls upwardly on containervent 1760 moving container vent 1760 away from carriage 1722. Solenoidrod 1782 is outwardly biased by a spring (not shown) such that whencontainer vent bore 1768 moves into axial alignment with inner hub bore1746, rod 1782 automatically extends into container vent bore 1768thereby holding container vent 1760 in the open position.

During use, lip cap assembly 1720 and container cover 1710 are part ofthe container assembly that undergoes a sterilization process cycle in asterilization chamber. After electronic sensor module 200-850 determinesthat the environment within container 402 during sterile processing weresufficient to meet or exceed a required set of environmentalcharacteristics (VSPM 1150) to insure sterility of the surgicalinstruments being sterilized, sensor module 200-850 transmits anelectrical signal via wireless transceiver 1773 or electrical cable 1779to solenoid driver 1775 instructing solenoid driver 1772 to closecontainer vent 1760.

Solenoid driver 1775 causes solenoid 1780 to retract solenoid rod 1782.When rod 1782 moves out of engagement with bore 1768, spring 1790 biasescontainer vent 1760 to move into recess 1730 thereby closing passage1796. The travel of container vent 1760 is limited by the abutment ofthe bottom of disc 1761 against cross members 1724. At the same time,O-ring 1764 is compressed between the disc outer side 1762 and the innersurface of ring 1728 forming a seal.

In one embodiment, when container vent bore 1767 moves into axialalignment with inner hub bore 1746, rod 1782 automatically extends intocontainer vent bore 1767 thereby holding container vent 1760 in theclosed position. In another embodiment, after container vent 1760 isclosed, sensor module 200-850 transmits an electrical signal viawireless transceiver 1773 or electrical cable 1779 to solenoid driver1775 instructing solenoid driver 1772 to cause solenoid 1780 to extendsolenoid rod 1782. In the extended position, the distal end of rod 1782is received by and engaged with bore 1767, thereby locking containervent 1760 to carriage 1722.

The use of automatic closing container assembly 1700 and automaticclosing lip cap assembly 1720 allows existing containers to beretrofitted with an automatic closing device that eliminates the needfor filters or filter assemblies. When passage 1796 is open, sterilantis able to readily enter and permeate container 402 withoutinterference.

After the container and its contents are subjected to the phase orphases of a sterilization cycle in which sterilant is introduced intothe container, passage 1796 is held open for an additional time period.This is to allow residual sterilant that may be in the container toevaporate and vent from the container. A benefit of allowing thisventing of the sterilant is that, if the sterilant is potentiallyhazardous to tissue, the likelihood of residual sterilant contacting apatient or hospital personnel is substantially eliminated.

In some versions of the invention the processor integral with the sensormodule closes cap 1760 over passage 1796 when the sensor measurementsindicate that the container environment has been at a select temperatureor pressure for a select period of time. In other versions of theinvention the processor closes the cap when the sensor measurementsindicate that the container has been cycled through a set number ofpressure set points.

XV. Operational Method to Determine if Validated Sterilization ProcessMeasurements in a Container have been Verified During a SterilizationProcess

Referring to FIG. 21, a flowchart of a method 2100 of verifying ifvalidated sterilization process measurements (VSPM) within a containerhave been achieved during a sterilization or disinfection process isshown. Method 2100 illustrates an exemplary method by which thecontainer assemblies 90, 300, 400, 500, 600, 700 800, 2900 and 4600(90-4600) and electronic sensor modules 200, 460, 560, 660, 760, 850,950, 1000, 1050, 1080 and 3500 (200-3500) presented within the precedingfigures perform different aspects of the processes that enable one ormore embodiments of the disclosure. Method 2100 is describedspecifically as being performed using container assembly 400 (FIG. 7A)and sensor module 1050 (FIG. 12B). However, method 2100 can be performedusing any of container assemblies 90-800 and electronic sensor modules200-3500. The description of the method is provided with generalreference to the specific components illustrated within the precedingfigures. In the discussion of FIG. 21, reference will also be made tocomponents from FIGS. 1-20.

Method 2100 begins at step 2102 where the equipment load of surgicalinstruments 180 is prepared for sterilization processing by an operator.Step 2102 includes the positioning of container 402 onto docking station1200 or 1300 and if the container has a connector, connecting thecorresponding connector 485, 1032 to the docking station. In analternate embodiment, connecting the sensor module to the dockingstation can be made through a wireless communication system. At step2102, handheld reader 1240 is used to scan the equipment load to besterilized. In and alternate embodiment, equipment load or contents IDcan be entered into the docking station or selected from a list or menucontaining all equipment loads or content IDs that have associated VSPMdata. Step 2102 further includes the placement of the equipment loadinto container 402 and enclosing the container with cover 450. Duringthe loading of surgical instruments, 180, the operator refers to thedisplay screen 1260 shown by docking station 1200 or 1300 to view thecorrect equipment load items and instrument loading orientation. Thisdisplay can help the operator in setting up the same equipment load andorientation that was used when validating and associated VSPM data tothe equipment load. In an optional step 2104, the sensors of electronicsensor module 460, 1050 are calibrated prior to use. Electronic sensormodules 460, 1050 are calibrated using docking station 1300. In anotheroptional step 2106, the surgical instruments 180 and/or tray 160 and/orcontainer 402 are wrapped in a sterile barrier material prior tosterilization processing.

At step 2108, sensor module memory 471, 1022 is programmed withvalidated sterilization process measurements (VSPM) data 1150 associatedwith the equipment load or content ID 1610. Container programmingsoftware 1461 (FIG. 17) acting on docking station processor 1410 (FIG.17) identifies the specific VSPM 1150 associated with the containerequipment load, using the data obtained from step 2102, and transmitsthe VSPM 1150 via the connector 485 for storage on the sensor modulememory 471, 1022. As described earlier, the transmitted VSPM 1150 arespecific to the equipment load (content ID) to be sterilized. In anotherembodiment, VSPM 1150 are transmitted via wireless means from thedocking station to the container memory for storage. In anotherembodiment, step 2108 confirms that the current VSPM data residing insensor memory is proper for the container equipment load andtransmitting of new VSPM 1150 from docking station to sensor memory isnot performed. This alternate embodiment may be used for sensor modulesthat are repeatedly used for the same equipment load for example sensormodule 760 that is mounted to a customized instrument rack 720 ordedicated container assembly.

In an additional optional step at block 2110, sterilization verificationsoftware 1152 acting on processor 1020 turns on a yellow light emittingdiode (LED) of LEDS 1030 (also shown as yellow LED 233 in FIG. 3)indicating to a user that the container assembly has not yet beenprocessed through a sterilization process cycle.

The container 402 is placed into the sterilization chamber 52 (FIG. 1)at step 2112. The container and its contents are subjected to asterilization process, step 2114. During the sterilization process, thechamber is heated, pressurized and a sterilant, such as steam orhydrogen peroxide vapor is into the sterilization chamber. By extensionthe environment inside the container is heated, pressurized and/orflooded with sterilant. The sterilization process may include a cooldown phase, drying phase or drawing a vacuum on the chamber to removeany residual condensed sterilant. The sterilization chamber is set tooperate using a set of nominal chamber process parameters (CPP) 66 (FIG.1).

During the sterilization process of step 2114, sterilizationverification software 1152 acting on processor 1020 monitors andcollects measurements from the respective electronic sensors with whichit is in communication during the sterilization process cycle. Thesensors measure the characteristics of the environment in the container.The software 1152 running on processor 1020 receives the signalsrepresentative of these environmental characteristics. These measuresare stored as data 1156 in memory 1022.

After the sterilization process is complete, software 1152, in step2116, compares the measurement data 1156 collected during thesterilization process, to the VSPM data 1150. At decision step 2118,sterilization verification software 1152 acting on processor 1020determines if the measurements data 1156 during the performedsterilization process meets or exceeds the VSPM data 1150 values withinthe VSPM data set to insure sterilization of the container contents. Forexample, if VSPM 1150 has a minimum temperature and time value of 250degrees Fahrenheit for 20 minutes, sterilization verification software1152 compares these values to the recorded time and temperatemeasurement values in data 1156.

The measured container characteristics may meet or exceed the VSPM data1150. If this condition tests true, the process of this inventionproceeds to step 2120 for containers that include closeable passages orvents. Step 2120 is the closing of the vent or passage. It should beunderstood that step 2120 is not executed immediately after theevaluation of step 2118 determines that the container environment metthe requirements for a validated sterilization process. Instead, step2120 is executed after the programmed time period, or detection of theset trigger event. This is ensure that between the completion of theactually sterilizing phases of the sterilization cycle and the closingof the vent there is sufficient time for the residual sterilant to ventfrom the container. For containers that do not contain closeablepassages, step 2120 is of course, not executed. Method 2100 proceeds tostep 2122.

Following the testing true evaluation of step 2118, the process proceedsto step 2122. In step 2122 processor 1020 indicates that the containercontents were successfully sterilized by turning on a green LED such asLED 230 (FIG. 3) or a green LED of LEDS 1030 (FIG. 12B) at step 2122

The evaluation of step 2118 testing false is interpreted as indicationthat the contents of the container have not been sterilized to thedesired levels. In response to this determination being made, theprocessor proceeds to a step 2126. In step 2126 the processor 1020presents an indication the contents of the container were notsuccessfully sterilized by turning on or flashing a red LED such as LED232 (FIG. 3) or a red LED of LEDS 1030 (FIG. 12B). Not shown is theopening of the vent or port in versions of the invention with a cap thatis selectively closed and open.

The completion of step 2122 or step 2126 is the end of a singlesterilization cycle.

XVI. Determining a Validated Sterilization Process Measurements for anIndividual Container Load

FIG. 22 is a flowchart of a method 2200 for determining a validatedsterilization process measurements (VSPM) 1150 for a single, definedcontainer load. This method can also be applied for determining avalidated disinfection process measurements with the primary differencebetween sterilization and disinfection is the quantity of biologicalchallenge organism reduction, that being an organisms reduction of 10^6for sterilization and an organism reduction of 10^3 for disinfection.Method 2200 is specifically discussed as being performed using containerassembly 400 (FIG. 7A) and sensor module 1050 (FIG. 12B). However, anyof the preceding container assemblies 90-800 and electronic sensormodules 200-3500 can be used to perform method 2200. The description ofthe method is provided with general reference to the specific componentsillustrated within the preceding figures. In the discussion of FIG. 22,reference will also be made to components from FIGS. 1-20.

Method 2200 begins at step 2202 where an equipment load of surgicalinstruments 180 is prepared for a Sterilization Validation by anoperator. At step 2202, the surgical equipment load is selected andprepared to be validated for a selected sterilization modality. Thesurgical equipment load includes all items inside of the sterile barrierthat are desired to be validated for sterilization. The equipment loadmay include surgical instruments 180 and an instrument tray or rack 160when desired. Step 2202 may further include the placement of thesurgical equipment load into container 402. At step 2202, all contentsof the container that make up the equipment load are documented.Documentation can include a written bill of materials, an electronicbill of material, descriptions and part numbers of the contents,photographs taken of the contents or a combination of these types ofdocumentation. The documented equipment load can be assigned a contentID 1610 as described in FIG. 19. In another embodiment, Step 2202 alsoincludes the placement of a biological challenge or inoculation of theequipment with biological challenge microorganisms in accordance withstandard practices for sterilization assurance level validation ordisinfection validation. One standard practice for inoculation of theequipment with microorganisms for steam sterilization can be found inANSI/AAMI/ISO TIR17665-2:2009, Sterilization of health careproducts-Moist heat-Part 2: Guidance on the application of ANSI/AAMI/ISO17665-1. Step 2202 includes completing the sterile barrier for thecontainer which may be wrapping the container in a sterile barriermaterial, installing new filters, setting the container ventsappropriately or other appropriate methods of completing the sterilebarrier for the container, sterile barrier type and sterilizationmodality. For container assembly 400, installing new filters 440 andlatching the lid assembly 450 to seal with container 402 completes thesterile barrier.

Also at step 2202, data recording software 1155 stored on memory 471,1022 is triggered to operate on processor 1020. Data recording software1155 monitors and records evaluation process measurements, as measuredby the sensor module, during a test sterilization process cycle forstorage on the sensor module memory 471, 1022.

The container 402 is placed into the sterilization chamber 52 (FIG. 1)and the test sterilization process cycle within sterilization chamber 52is started (step 2204). The sterilization chamber is typically set tooperate using a set of nominal chamber test process parameters. Duringthe test sterilization process cycle, the sterilization chamber isheated, pressurized and a sterilant, such as steam or hydrogen peroxidevapor is introduced into the sterilization chamber. The sterilizationprocess cycle typically includes a cool down phase or an evacuationphase to remove any residual and/or condensed sterilant.

Also, at step 2204, data recording software 1155 acting on processor1020 monitors and collects measurement data from the respectiveelectronic sensors with which it is in communication during the teststerilization process. The sensors record the evaluation processmeasurements and conditions within the sterile barrier. The collectedmeasurement data is stored in memory 1022 as data 1156. For example,data recording software 1155 acting on processor 1020 collects watervapor data from water vapor sensor 1024, pressure data from pressuresensor 1026, temperature data from temperature sensor 1028 and hydrogenperoxide concentration data from hydrogen peroxide gas sensor 1052. Insome embodiments, these data are simultaneously tracked and recorded asa function of time so as to capture the evaluation process measurementsexperienced inside of the sterile barrier on a time basis.

At step 2206, container 402 is removed from the sterilization chamber 52and the equipment load is evaluated for the level of sterilizationachieved. In one embodiment, an operator incubates and reads thebiological challenge (or inoculated microorganisms) and determines ifthe survival rate of the microorganisms is below a pre-determineddesired level. In another embodiment, a 0% survival rate of themicroorganisms indicate that the evaluation process measurements areadequate to insure destruction of all pathogens during sterilizationprocessing.

If the level of sterilization is not acceptable, the operator can modifythe equipment load, the nominal sterilization process parameters or thesterile barrier. The operator can modify one or more of these items, orany other controllable items that can affect the test sterilizationprocess results. For example, the modification of chamber (52) processparameters can include increasing one or more process parameters of thesterilization chamber 52. In one embodiment, the temperatures level andthe lethal portion of the test sterilization process time are increasedin step 2208. In another embodiment, step 2208 includes modifying thecontents of container 402. For example, fewer surgical instruments 180are placed inside the sterile barrier. Method 2200 then returns to step2202 where the container 402 and equipment load is re-processed insterilization chamber 52 repeating the steps until a desired level ofsterilization is achieved at step 2206.

In response the sterilization level of the equipment load beingacceptable, the recorded sensor measurements are collected from sensormodule memory 1022 and the measurements become validated sterilizationprocess measurements (VSPM) associated to the equipment load. VSPM 1150are based on the received evaluation measurement data 1156 that werefunctionally confirmed to act on the contaminants within the equipmentload wherein the evaluation measurements become validated measurements.In one embodiment, process measurement validation software 1466 actingon docking station processor 1410 reads the recorded evaluationmeasurement data 1156 from sensor module memory 1022 and stores the dataon docking station memory 1412 at step 2210. Also in this embodiment atstep 2210, an operator uses the evaluation measurement data 1156recorded by the sensor module to determine and generate values forvalidated sterilization process measurements (VSPM) 1150. After the VSPM1150 are determined, the operator inputs VSPM 1150 to docking station1200, 1300 and directs VSPM 1150 to be stored to memory 1412.

In another embodiment, process measurement validation software 1466acting on docking station processor 1410 automatically generates VSPM1150 from evaluation measurement data 1156 and stores the data ondocking station memory 1412 at step 2210. In all embodiments,correlation of the equipment load to the VSPM completes process step2210 for the desired level of sterilization.

In an optional step 2212, the operator establishes measurement limitsfor VSPM 1150. Measurement limits could include upper and lower limitvalues for one or more sensor reading included in VSPM 1150 data set.Reading limits could include only an upper or only a lower limit. Forexample, in one embodiment, an operator can determine that a minimum orlower time limit experienced during the test sterilization processing is20 minutes and a maximum or upper time limit is 40 minutes. In anotherembodiment, an operator can determine that a lower temperature limitexperienced during the test sterilization process is 270° Fahrenheit.After the measurement limits are determined in this optional step, theoperator sets the measurement limits for VSPM 1150 and directs themeasurement limits to be stored to memory 1412. Optional step 2212 iscompleted when the measurement limits for VSPM 1150 are correlated tothe equipment load for the desired sterilization level. Method 2200 thenends.

It should be understood that the definition of determining whatconstitutes whether or not a load of instruments was successfullysterilized in step 2206 is a function of the acceptable degree ofsterilization for the instruments. Some instruments are consideredadequately sterilized if they are only subjected to disinfection.Disinfection it is understood has a lower sterility assurance level thansterilization. Thus method 2200 as well as the sterilization process andequipment of this invention can be used to provide instruments that aresterile but not as sterile as typically required for instruments appliedto tissue below the skin.

Once a set of validated sterilization process measurements are generatedfor a container load, these measurements are used to determine whetheror not the load was sterilized even if the load was placed in acontainer different from the container used to generate the VSPM for theload. This is because changing form of the sterile barrier (thecontainer) that surrounds the load essentially only changes the rate atwhich the environment around the load changes during the sterilizationprocess.

For example, when the only difference between two containers is theirporosities, the key difference in the environmental characteristics inthe containers will be the rate at which these characteristics change.Thus, when sterilant is introduced into both containers, theconcentration of the sterilant in the more porous container will rise ata faster rate than the concentration in the less porous container. Thuswhen the same load is subjected to sterilization process in the twodifferent containers, the primary difference will be the time it takesfor the concentration of sterilant adjacent the instruments forming theload to reach the desired, the validated levels. As long as theconcentration of sterilant is at the validated concentration level forthe validated time period, the instruments forming the load will reachthe desired sterility level.

This feature of the invention frees the hospital from having tosterilize a specific load of instrument by always placing thoseinstruments in a specific container. If a container a designed for a setof instruments is not available for use, the instruments can be placedin an alternate container. It is only necessary that sensing unitintegral with this container be able to (1) measure the characteristicsinternal to the container and (2) compare the measured environmentalcharacteristics to the VSPM for the load. When these conditions are met,the alternative container can hold instruments during sterilization andits sensing unit will provide an indication regarding whether or not theinstruments were successfully sterilized.

XVII. Operational Method to Validate and Correlate ValidatedSterilization Process Measurements

Referring to FIG. 23, a flowchart of another method 2300 of determining,correlating and validating sterilization process measurements (VSPM)1150 is shown. Method 2300 is discussed as being performed usingcontainer assembly 400 (FIG. 7A) and sensor module 1050 (FIG. 12B).However, any of the preceding container assemblies 90-800 and electronicsensor modules 200-1080 can be used to perform method 2300. Thedescription of the method is provided with general reference to thespecific components illustrated within the preceding figures. In thediscussion of FIG. 23, reference will also be made to components fromFIGS. 1-20.

Method 2300 describes the steps for an operator to validate andequipment load through a Sterilization Assurance Level Validation. Atstep 2302, the surgical equipment load is selected and prepared to bevalidated for a selected sterilization modality for example steam,chemical or hydrogen peroxide. The surgical equipment load includes allitems inside of the sterile barrier that is desired to be validated forsterilization. Step 2302 includes the positioning of container 402 ontodocking station 1200 or 1300 and if the container has a connector,connecting the corresponding connector 485, 1032 to the docking station.At step 2302, all contents of the container that make up the equipmentload are documented. Documentation can include a written bill ofmaterials, an electronic bill of material, descriptions and part numbersof the contents, photographs taken of the contents or a combination ofthese types of documentation. At step 2302, handheld reader 1240 can beused to scan container 402, tray 160 and the surgical instruments 180 toaid in the documentation of the equipment load.

At step 2304, a biological challenge device, biological indicator or amicroorganism inoculation process is used to create a biologicalchallenge for Sterilization Assurance Level Validation. These biologicaldevices or processes include a known number of microorganisms that havea resistance to the mode of sterilization in use. These biological loadsare used to determine if the proper sterilization level with a teststerilization process has been achieved for a given equipment load.

At step 2306, the equipment load is placed into container 402 thatcontains electronic sensor module 460 and is enclosed with cover 450assembly including appropriate sterile barrier filters 440. At step2308, data recording software 1155 stored on memory 471, 1022 istriggered to operate on processor 1020. Process measurement validationsoftware 1466 (FIG. 17) acting on docking station processor 1410 (FIG.17) transmits instructions for data recording software 1155 to monitorand record process measurements during a test sterilization processcycle for storage on the sensor module memory 471, 1022. Data recordingsoftware 1155 acting on processor 1020 monitors and records the processmeasurements during the test sterilization process cycle. At optionalstep 2310, the sterile barrier appropriate for the type of container andsterilization process is completed prior to placing the container intothe sterilizer chamber 52.

The container 402 is placed into the sterilization chamber 52 (FIG. 1)and the test sterilization process cycle within sterilization chamber 52is started (step 2312). During the sterilization process cycle, thesterilization chamber is heated, pressurized and a sterilant, such assteam or hydrogen peroxide vapor are introduced into the sterilizationchamber. The sterilization process cycle typically includes a cool downphase and drawing a vacuum on the chamber to remove any residual and/orcondensed sterilant. The sterilization chamber is set to operate using anominal set of test process parameters.

Also, at step 2312, software 1155 monitors and collects time based datafrom the respective electronic sensors with which it is in communicationduring the sterilization process cycle. The sensors measure theenvironmental characteristics inside the sterile barrier. The collectedmeasurements are stored as data 1156. For example, data recordingsoftware 1155 acting on processor 1020 collects water vapor or humiditydata from humidity sensor 1024, pressure data from pressure sensor 1026,temperature data from temperature sensor 1028 and hydrogen peroxideconcentration data from hydrogen peroxide vapor sensor 1052. Measurementdata can be stored into memory 1022 until transferred to docking stationmemory at step 2320.

After the test sterilization process is complete, the in step 2314 theappropriate tests are executed to determine whether or not theinstruments forming the load are sterile to the acceptable level. Themeans by which theses are performed are not part of the invention.

At decision step 2316, an operator determines the results of the test ofstep 2314 indicate whether or not the instruments forming the load wereacceptably sterilized. If the evaluation of step 2316 tests false, theinstruments are subjected to a subsequent test sterilization process,steps 2306-2312 are reelected. the subsequent sterilization process is,prior to the execution of this process, in a step 2318, modified sothere is at least one difference between the just executed teststerilization process and the subsequent test sterilization process.This modification to the sterilization process can include increasingone or more process parameters of the sterilization chamber 52. In oneembodiment, the temperature level or the process cycle time areincreased in step 2318. In another embodiment, step 2318 includesmodifying the contents of container 402. For example, fewer surgicalinstruments 180 are use for the equipment load or a different type ofsterile barrier design can be used.

After the execution of the subsequent sterilization process, theinstrument load is subjected to the previously described, sterilizationtesting, step 2314. Step 2316 is reexecuted to determine whether or notthe results of the test indicate that the instruments forming thecontainer load were successfully sterilized.

After a sterilization process, the results of the evaluation of step2316 can test true. When this event occurs, the operator designates thedata 1156 recorded by the sensors to determine values as the validatedsterilization process measurements (VSPM) 1150 for the load. The VSPM1150 data are associated to the load in step 2302. After the VSPM 1150are determined, the operator inputs VSPM 1150 and associated equipmentload to docking station 1200, 1300 using keyboard 1426 or an electronicdata transfer method and directs VSPM 1150 to be stored to memory 1412in association with the equipment load.

In another embodiment, process measurement validation software 1466acting on docking station processor 1410 automatically generates VSPM1150 from real time measurement data and stores the data on dockingstation memory 1412 at step 2322. In all embodiments, correlation of theequipment load to the VSPM completes process step 2322 for the desiredlevel of sterilization.

In an optional step 2324, the operator establishes measurement limitsfor VSPM 1150. Measurement limits include upper and/or lower limitvalues for one or more process measurements to be included in VSPM 1150.For example, in one embodiment, an operator can determine that a minimumor lower temperature limit for the desired sterilization level is 270°F. for the first 2 minutes and another minimum temperature limit 272° F.for the next 3 minutes. The determination of process limits is performedusing data collected from one or more sterilization process validationcycles each with different sterilization processing measurements andconditions. After the process measurement limits are determined, theoperator sets the process measurement limits for VSPM 1150 andcorrelates them to the equipment load using keyboard 1426 or electronicdata transfer and directs the process measurement limits to be stored tomemory 1412. Additionally, the correlation of VSPM data set to theequipment load is stored to memory 1412. Method 2300 then ends.

XVIII. Operational Method to Determine and Correlate ValidatedSterilization Process Measurement Using Overkill Methods

Referring to FIG. 24, a flowchart of an additional method 2400 ofdetermining and correlating validated sterilization process measurements(VSPM) 1150 is shown. Method 2400 is discussed as being performed usingcontainer assembly 400 (FIG. 7A) and sensor module 1050 (FIG. 12B).However, any of the preceding container assemblies 90-800 and electronicsensor modules 200-1080 can be used to perform method 2400. Thedescription of the method is provided with general reference to thespecific components illustrated within the preceding figures. In thediscussion of FIG. 24, reference will also be made to components fromFIGS. 1-20.

Method 2400 starts at step 2402 where the equipment load of surgicalinstruments 180 is selected for sterilization. The equipment load isdefined as all items inside of the sterile barrier which can include notonly the surgical instruments 180 but also an instrument rack 160 whenpresent. Instrument racks can aid in affecting sterilization bypositioning instruments with difficult to reach locations inpreferential orientations for the steriliant to penetrate and performsterilization. At step 2404, a biological test device or biologicalchallenge organisms are placed within the equipment load typically at adifficult to sterilize location(s). For example, if the equipment loadhas a instrument with a small diameter and a long closed end lumen, abiological challenge can be placed into the hardest to reach location atthe closed end. The biological challenge is processed through the teststerilization process cycle along with the surgical instruments.

The biological challenge carries a biological agent. During a successfulsterilization process cycle, the biological agent is typically killed.The biological challenge includes a known number of microorganisms thathave a know resistance to the mode of sterilization in use. Forvalidation of a disinfection process, a minimum of 3 log reduction inthe number of surviving microorganisms is required. For a biologicalchallenge starting with 10^6 organisms, a 3 log reduction would resultin at least 10^3 organisms killed. For validation of a sterilizationprocess for an equipment load, a minimum of 6 log reduction in thenumber of surviving microorganisms is required.

In an optional step 2405, an operator documents the type of biologicalchallenge used and the location of the biological challenge within theequipment load. The operator may enter this information into the dockingstation using keyboard 1426 or electronic data transfer (i.e. importingscans or documents). In another embodiment, step 2405 includes using acamera to take a picture of the biological challenge locations on theequipment load in container 402 and saving the image captured to dockingstation memory 1412.

The equipment load is documented and then is placed into container 402that contains electronic sensor module 460 and is enclosed with cover450, completing the sterile barrier at step 2406. To document theequipment load, the operator inputs the type and quantity of surgicalinstruments, the type of tray and other items within the sterilebarrier. Container 402 is placed on docking station 1200 or 1300 andconnected to the docking station using connector 485.

In another optional step 2407, the operator documents the equipment loadof surgical instruments to be sterilized and the location of the sensorswithin container 402 with a photograph. The photograph can capture theequipment load, the orientation of the instruments and equipment withinthe load and the type and location of the sensors within the container.Step 2407 includes using a camera to take a picture of the contents andsensors within container 402 and saving the image captured to dockingstation memory 1412.

At step 2408, data recording software 1155 stored on memory 471, 1022 istriggered to operate on processor 1020. Process measurement validationsoftware 1466 (FIG. 17) acting on docking station processor 1410 (FIG.17) transmits instructions for data recording software 1155 to monitorand record process measurements during a test sterilization processcycle for storage on the sensor module memory 471, 1022. Data recordingsoftware 1155 acting on processor 1020 monitors and records the processmeasurements during the test sterilization process cycle.

The container 402 is placed into the sterilization chamber 52 by anoperator (FIG. 1) and the test sterilization process cycle withinsterilization chamber 52 is started (step 2412). The test sterilizationprocess cycle at step 2412 is performed using a one-half teststerilization process within the sterilization chamber 52. For example,a one-half test sterilization process for a standard 4 minute autoclavesteam cycle at 270° F. would be a 2 minute autoclave steam cycle at 270°F. In another example, a one-half test sterilization cycle for HydrogenPeroxide 4 pulse cycle would be a 2 pulse cycle. During thesterilization process cycle, the sterilization chamber 52 is heated,pressurized and a sterilant, such as steam or hydrogen peroxide vapor isintroduced into the sterilization chamber according to the half lethalchamber process parameter values.

Also, at step 2412, data recording software 1155 acting on processor1020 monitors and collects time based data from the respectiveelectronic sensors with which it is in communication during thesterilization process cycle. The sensors monitor the operating processmeasurements and conditions within the respective container they aremounted. The collected time based measurement data are stored in memory1022 as data 1156. For example, data recording software 1155 acting onprocessor 1020 collects humidity data from humidity sensor 1024,pressure data from pressure sensor 1026, temperature data fromtemperature sensor 1028 and hydrogen peroxide concentration data fromhydrogen peroxide gas sensor 1052. These measurements are typicallytaken simultaneously as a function of time.

After the one-half test sterilization process is completed, thebiological challenge is extracted, placed in a growth medium andcultivated for a period of time and then analyzed for microorganismgrowth. A level of microorganism survival is determined in step 2414. Inone embodiment, step 2414 includes determining if a greater than a 6 logreduction in the number of surviving microorganisms has occurred.

At step 2416, an operator determines if 100 percent or the desiredquantity of the biological challenge microorganisms have been killed. Inresponse to not all of the microorganisms being killed in step 2414,(i.e. some quantity survived and the level of sterilization is notacceptable), the set of test chamber process parameters can be modifiedat step 2418 by an operator. The modification of test chamber processmeasurements can include increasing one or more process parameters ofthe sterilization chamber 52. In one embodiment, the temperature levelor the process cycle time are increased in step 2418. In anotherembodiment, step 2418 includes modifying the contents of container 402.For example, fewer surgical instruments 180 are placed in tray 160 or adifferent type of sterile barrier material can be used.

A new biological challenge is placed within the load and method 2400returns to step 2404 as shown in FIG. 24, where the container 402 isre-processed in sterilization chamber 52 using the new one-half teststerilization chamber process.

In response to all of the microorganisms being killed in step 2414,(i.e. zero percent survival), container 402 is placed on docking station1200, 1300 and the docking station is connected to container connector485. Process measurement validation software 1466 acting on dockingstation processor 1410 reads the recorded measurement data fromcontainer memory 1022 and stores the data 1156 on docking station memory1412 at step 2420.

At step 2422, an operator uses the data 1156 recorded by the sensors andcorrelates it to the equipment load and level of sterilization. Thiscorrelation is based on the received measurement data that werefunctionally confirmed to act on the biological challenge resulting inthe desired level of sterilization.

In another embodiment, process measurement validation software 1466acting on processor 1410 automatically generates one-half teststerilization values from the time based measurement data.

At step 2424, the lethal portion of the test sterilization process cycleis doubled to generate VSPM 1150. As shown in the previous examples, foran autoclave steam cycle at 270° F. the test cycle time above 270° F.portion of the test sterilization process cycle would be doubled. Inanother example, the lethal portion of the one-half test sterilizationcycle for Hydrogen Peroxide, namely the number of hydrogen peroxidepulses, would be doubled from 2 pulses to 4 pulses. VSPM 1150 could begenerated by process measurement validation software 1466. Processmeasurement validation software 1466 acting on processor 1410 increasesthe lethal portion of the test process operating time by a factor oftwo. In an example embodiment, if all of the biological organisms arekilled after a lethal process cycle time of 20 minutes, the processcycle time is increased to 40 minutes by process measurement validationsoftware 1466. The new VSPM 1150 with the increased cycle time is thenstored to memory 1412. After the VSPM 1150 are determined, the operatorinputs VSPM 1150 and correlated equipment load to docking station 1200,1300 using keyboard 1426 or an electronic data transfer method anddirects VSPM 1150 to be stored to memory 1412 in association with theequipment load.

In an optional step 2426, the operator establishes process limits forVSPM 1150. Process limits could include upper and/or lower limit valuesfor one or more process measurements included in VSPM 1150. For example,in one embodiment, an operator can determine that a minimum or lowerhydrogen peroxide concentration limit for sterilization processing is 8mg/L and a maximum or upper hydrogen peroxide concentration limit is 10mg/L. The determination of process limits could be performed using datacollected from multiple sterilization process cycles each with differentsterilization processing measurements and conditions. After the processlimits are determined, the operator sets the process limits for VSPM1150 using keyboard 1426 or the process measurement validation software1466 transfers and directs the process limits to be stored to memory1412. Additionally, the correlation of VSPM to the equipment load isstored to memory 1412. Method 2400 then ends.

XIX. Operational Method of Monitoring Sterility of Container Contents

Referring to FIG. 25 a flowchart of a method 2500 of monitoringsterility of the contents of container is illustrated. Method 2500 isparticularly described as being performed using container assembly 400(FIG. 7A). However, method 2500 can be utilized with any of thepreviously described container assemblies. The description of the methodis provided with general reference to the specific componentsillustrated within the preceding figures. In the discussion of FIG. 25,reference will also be made to components from FIGS. 7A-7D, and 14 andsensor modules 200.

Method 2500 starts at step 2502 where sterile monitor software 1158acting on processor 1020 monitors the electrical signals transmittedfrom Hall effect sensors 480. At step 2504, sterile monitor software1158 determines if the Hall effect sensor signal has changed to indicatethat the magnetic field is no longer detected.

In response to no change in the Hall effect sensor signal, sterilemonitor software 1158 acting on processor 1020 continues to monitor theelectrical signals transmitted from Hall effect sensors 480 (step 2502).In response to a change in or loss of the Hall effect sensor signal,sterile monitor software 1158 acting on processor 1020 causes the greenLED of LEDS 487 to turn off and causes the red LED of LEDS 487 to beilluminated at step 2506 indicating the container latch was changedpotentially allowing a breach to sterilization inside container. TheHall effect sensor signal changes with latch 446 movement or cover 450movement like lifting away from container 402 or is removed fromcontainer 402. When the magnets 448 are moved away from Hall effectsensors 480 causing a loss of magnetic field to sensors 480. Thelighting of the red LED indicates that the contents of container 402,such as surgical instruments 180, are at an increased risk of a sterilebreach or are no longer sterile. Method 2500 then terminates.

XX. Operational Method of Loading Surgical Instruments into a Container

Referring to FIG. 26 a flowchart of a method 2600 of loading surgicalinstruments into a container prior to sterilization processing is shown.Method 2600 is explained as being performed using container assembly 100(FIGS. 2-4C) and docking station 1200 (FIG. 15). However, method 2500can be utilized with any of the described container assemblies withsensor modules or docking stations. The description of the method isprovided with general reference to the specific components illustratedwithin the preceding figures. In the discussion of FIG. 26, referencewill also be made to components from FIGS. 2-4C, 15 and 17.

Method 2600 begins at step 2602 where an operator positions container100 to rest on docking station shelf 1212. In an optional step,electronic sensor module 200 is connected to docking station 1200 forcommunication via cable 146.

At step 2604, the operator scans the bar code or RFID tag 135 oncontainer 100 and the bar code or RFID tag 167 on tray 160 usinghandheld reader 1240. At step 2606, container loading software 1464acting on processor 1410, searches container/tray configuration data1465, selects a display screen 1260 from data 1465 corresponding to therespective scanned bar codes and RFID tags and causes the display screen1260 to be shown on display 1230. The display screen 1260 illustratesthe surgical instruments 180 to be loaded into tray 160 and the correctposition and orientation of the surgical instruments 180 to be loaded.

The operator scans a first surgical instrument bar code or RFID tag 181at step 2608 using handheld reader 1240. At decision step 2610,container loading software 1464 acting on processor 1410, determines ifthe scanned surgical instrument 180 is a correct surgical instrument tobe loaded into tray 160 using container/tray data 1465.

In response to the scanned surgical instrument 180 being incorrect toload into tray 160, container loading software 1464 acting on processor1410, indicates that the wrong surgical instrument has been selected forloading by changing the video screen 1260 at step 2612. In oneembodiment, a red warning sign is flashed on display 1230 and an alarmsounded instructing the operator that they have selected an incorrectinstrument. Method 2600 then returns to step 2608 where the nextsurgical instrument 180 to be loaded is scanned by the operator.

In response to the scanned surgical instrument 180 in step 2608 beingcorrect to load into tray 160, the operator places the surgicalinstrument 180 into tray 160 with reference to the position andorientation information illustrated on display screen 1260 (step 2614).Display screen 1260 guides the operator during placement of surgicalinstruments into tray 160.

While not shown as a separate step, the container loading software 1464running on processor 1410 determines if the tray 160 is fully loadedwith surgical instruments 180. If this evaluation tests negative, theoperator in a reexecution of step 2608 scans the next instrument 180 tobe loaded. When the evaluation determines the tray is full the processor1410 at step 2618 causes a display screen 1260 to indicate all of thesurgical instruments are loaded into tray 160 and that container 100 isready for further processing.

At step 2616, container loading software 1464 acting on processor 1410,transmits container/tray data 1465 to hospital computer system 1454 toupdate database 1456 with the current location and status of the loadedcontainer, tray and surgical instruments. In an example embodiment,container/tray data 1465 updates database 1456 with the location ofcontainer 100, the specific surgical instruments 180 contained in tray160 and that the container and contents are currently not sterile.

XXI. Operational Method of Calibrating Sensors

Referring to FIG. 27, a flowchart of a method 2700 of calibratingsensors or verifying sensor accuracy and electronic sensor modules isshown. Calibration and sensor accuracy verification is used to check(verify) and/or adjust (calibration) the sensor response to a known setof simulated or generated environment conditions. Calibration and sensoraccuracy verification methods are used to insure sensor measurements areaccurate when used to generate VSPM data or verify VSPM data with sensormodules. Method 2700 is explained as being performed using containerassembly 400 (FIGS. 7A-7C), sensor module 1050 (FIGS. 12B, 14) anddocking station 1300 (FIGS. 16, 17). However, method 2700 can beutilized with any of the sensor modules described herein. Thedescription of the method is provided with general reference to thespecific components illustrated within the preceding figures.

Method 2700 begins at step 2702 where an operator positions containerassembly 400 to rest on docking station shelf 1342 or into calibrationchamber 1320 and connects docking station cable 1340 to containerconnector 485. The operator also connects docking station connectors1336 and 1338 together such that docking station 1300 is incommunication with container assembly 400 for sensor calibration. Morespecifically, docking station controller 1402 is in communication withelectronic sensor module controller 1120.

At step 2704, sensor calibration software 1460 acting on processor 1410,causes a display screen 1260 to be shown on display 1230. If the sensormodule has sensors that require calibration or require sensorperformance verification, the display screen 1260 illustrates thecontainer 402 and sensors to be calibrated and operator instructions toaffect a proper calibration or sensor verification. If not alreadypositioned, the operator places container assembly 400 into calibrationchamber 1320 and closes door 1326.

For example at step 2708, sensor calibration software 1460 acting onprocessor 1410, causes calibration chamber 1320 and electronic sensormodule 1050 to execute a sensor calibration process or sensorverification cycle. Depending on the type of sensors that requirecalibration or verification, various systems within the docking stationare be used independently or in combination to calibrate or verifysensor accuracy. Sensor calibration process at step 2708 may includeturning on and operating steam generator 1430, hydrogen peroxidegenerator 1432, pressure pump 1434, vacuum pump 1436 and heater 1438.Steam generator 1430, hydrogen peroxide generator 1432, pressure pump1434, vacuum pump 1436 and heater 1438 all operate according to apre-defined set of calibration operating parameters generated by sensorcalibration software 1460 acting on processor 1410 and transmitted viainput/output interface circuit 1414.

During the sensor calibration cycle at step 2708, steam generator 1430supplies a standard concentration of steam to calibration chamber 1320and hydrogen peroxide generator 1432 supplies a standard concentrationof hydrogen peroxide gas to calibration chamber 1320. Pressure pump 1434increases the pressure in calibration chamber 1320 to a standardpressure during the first part of the calibration cycle. Vacuum pump1436 draws a standard vacuum level in calibration chamber 1320 duringthe later part of the calibration cycle. Heater 1438 heats calibrationchamber 1320 to a pre-determined standard temperature. One or morestates of each generator system can be generated in order to affect aknown single point, two point or multiple point parameter state tocalibrate or verify the sensor response.

In another embodiment at step 2708, sensor calibration software 1460acting on processor 1410, triggers sensor calibration software 1154acting on processor 1020 to operate one or more generator systems tocalibrate water vapor sensor 1024, pressure sensor 1026, temperaturesensor 1028 and hydrogen peroxide sensor 1052.

At step 2710, sensor calibration software 1460 acting on processor 1410,queries and receives feedback from calibration software 1154 acting onprocessor 1020 as to the success or failure of the calibration processon each sensor. Calibration software 1460 acting on processor 1410,determines if all of the sensors have been correctly calibrated orverified to the within specified accuracy.

In response to one or more of the sensors 1024-1052 not being correctlycalibrated to the specified calibration measurements, the specificsensor(s) are identified and flagged for inspection and repair at step2714. Calibration software 1460 acting on processor 1410, causes adisplay screen 1260 to be shown on docking station 1300 indicating thedefective sensor(s). In another embodiment, calibration software caninstruct sensor module to provide a visual indication, for example usingflashing LEDs, to the operator that a calibration failure occurred.Method 2700 then ends.

In response to the sensors 1024-1052 being correctly calibrated and/orverified to the specified measurements, the sensors are indicated asbeing successfully calibrated at step 2712. Calibration software 1460acting on processor 1410, causes a display screen 1260 to be shown ondocking station 1300 indicating that all of the sensors 1024-1052 incontainer assembly 400 have been correctly calibrated or verified andare ready to be used in their appropriate sterilization process. Method2700 then terminates.

In alternative versions of the invention, sensor calibration software1460 is set to require the calibration of the sensors based on thenumber of times the sensors are used.

XXII. Method of Monitoring Container Usage and Billing on a Fee Per UseBasis

Turning to FIG. 28, a flowchart of a method 2800 of monitoring containerusage and billing on a fee per use basis is shown. Method 2800 isexplained as being performed using docking station 1200 (FIG. 18),manufacturer computer system 1510 (FIG. 18) and hospital computer system1454 (FIG. 18). Method 2800 is used with any of the previously describedcontainers 90-800. Method 2800 is described with reference to FIG. 18and FIG. 28.

Method 2800 begins at step 2802 where usage software 1470 operating onprocessor 1410 monitors and tracks the usage of containers or sensormodules within a medical facility. When docking station 1200 is usedduring container loading and/or sensor programming typically prior tosterilization, usage software 1470 tracks the frequency of use of thecontainers or sensors, generates usage data 1472 and stores the usagedata to memory 1412. In another embodiment, usage software 1472 readsthe sensor module memory and extracts usage data for processing. In yetanother embodiment, usage software 1472 clears or resets usage data insensor module memory. Usage software 1470 operating on processor 1410periodically transmits usage data 1472 to manufacturer computer system1510 at step 2804. In one embodiment, usage data 1410 is transmitted ona weekly basis from docking station 1200 to manufacturer computer system1510.

At step 2806, invoice software 1530 acting on manufacturer computersystem processor 1520 periodically generates invoices 1532 based onusage data 1472. The invoices are stored to memory 1522. Invoicesoftware 1530 operating on processor 1520 periodically transmitsinvoices 1532 to hospital computer system 1454 at step 2808. In oneembodiment, invoices 1532 are generated and transmitted on a weeklybasis from manufacturer computer system 1510 to hospital computer system1454. At step 2810, hospital computer system 1454 receives invoices 1532and stores the invoices to memory 1572 for payment processing. Method2800 then ends.

Method 2800 is used in conjunction with a business model where dockingstation 1200, sensor modules or containers 90-800 are leased or rentedto a medical facility or hospital. The medical facility or hospital paysfor using the docking stations, sensor modules and containers on a feeper use basis as determined by usage software 1470 and invoice software1530.

XXIII. Container with Removable Sensors

FIGS. 29-39 illustrate a container assembly 2900 with removable sensors.With specific reference to FIGS. 29 and 30, container assembly 2900comprises container 2902 and a removable sensor apparatus 3000.Removable sensor apparatus 3000 is described below including an optionalembodiment that contains a tamper evident sterile barrier monitoringsystem. This optional embodiment temper evident sterile barriermonitoring system is described below using one or more magnets and halleffect sensors. Other tamper evident systems, like breakable plasticmechanical locks, can be used to notify operators that the sterilebarrier has been tampered with and these other tamper evident systemscan be combined with removable sensor apparatus 3000.

Container 2902 of FIGS. 29 and 30 is the same as the previouslydescribed container 402 of FIG. 7A except that rectangular shapedopenings 414 and 418 in side panel 406 have been omitted and a circularshaped opening 415 has been added in side panel 406. Cover 450 of FIGS.29 and 30 is the same as the previously described cover 450 of FIG. 7Aexcept that magnet 488 has been removed from cover 450 and mounted tothe interior facing surface of container lid latch 496 (see FIG. 41).Cover 450 includes disposable filters 440 that are retained to cover 450by filter support members 442.

Filters 440 are formed from a microbial barrier material that ispermeable to sterilant. Filter 440 allows sterilant to pass from theoutside of cover 450, through holes 459, through filter 440, throughapertures 445 and into interior cavity 420 of container 2902 where thesterilant contacts surgical instruments contained therein. Filters 440also form a microbial barrier preventing microorganisms from enteringinto container assembly 2900 after processing through a sterilizationprocess. Filters can be present on one or more other container panels inreplacement of or in addition to lid filter shown in container assembly2900. This allows one or more filtered paths for sterilization agents toenter and exit container assembly while maintaining a microbial barrier.

A tray 160 (FIG. 2) containing surgical instruments 180 (FIG. 2) to besterilized is placed into container 2902 so that tray 160 rests onbottom panel 407. Cover 450 is retained to container 2902 using lockinglid latch 496. Locking lid latch 496 is rotated by a user upwardly overcover steps 446 and then downwardly to a locked position where cover 450is retained to and locked to container 2902.

Referring to FIGS. 31, 32 and 33, details of removable sensor apparatus3000 are shown. Removable sensor apparatus 3000 comprises a sensormodule receiver 3100 and a removable sensor unit, device or module 3500.Removable sensor unit or module 3500 can be inserted into and removedfrom sensor module receiver 3100.

Sensor module receiver 3100 includes receiver housing 3102, retainingring 3200, housing cover 3250, carriage assembly 3300 and lock mechanism3400 all of which can be formed from injection molded plastic or metals.Receiver housing 3102 has a generally square shaped central body 3104with an integral attached triangular shaped extension 3105. Body 3104has a front surface 3106, rear surface 3108 and five sides 3110. Twoslots 3112 are defined in two of the sides 3110. The sides 3110 with theslots are parallel and diametrically opposed to each other on oppositesides of body 3104. The length of slots 3112 are defined by thethickness of body 3104. Threaded bores 3114 are defined at the base ofeach slot 3112. Bores 3114 extend perpendicularly from the base of eachslot 3112 partially into body 3104.

With specific reference to FIG. 33, a cylindrical sleeve 3118 extendsperpendicularly away from front surface 3106 and terminates at a distalend 3120. A step 3128 is located on the sleeve outer surface and ispositioned approximately half way between distal end 3120 and a groove3126. Step 3128 separates a proximal annular outer surface 3123 and adistal annular outer surface 3124. Proximal annular outer surface 3124has a larger diameter than distal annular outer surface 3124. Threads3129 are defined on outer surface 3123. Sleeve 3118 further includes aninner annular surface 3122 that defines a thru bore 3125. Annular groove3126 is located in body front surface 3106 surrounding sleeve 3118 atthe base or proximal end of sleeve 3118. Groove 3126 is dimensioned toreceive container O-ring 3127 (FIG. 32). O-ring 3127 is seated in groove3126. After assembly, container O-ring 3127 forms a seal betweenreceiver housing 3102 and container panel 406 by compressing seal 3127between interior panel surface 412 of pane 406 through threadedcompression with retaining ring 3200.

Two diametrically opposed portions of distal end 3120 are removed todefine diametrically opposed arcuate shaped recesses 3132. The remainingportions of distal end 3120 form two diametrically opposed arcuateshaped shoulders 3134. The inner most edges of shoulders 3134 adjacentinner annular surface 3122 are beveled. Two threaded bores 3136 aredefined in the base of each recess 3132. Bores 3136 extendperpendicularly from the base of each recess 3132 partially into sleeve3118.

Fingers 3138 and 3140 extend perpendicularly away from inner annularsurface 3122 partially into thru bore 3125. Fingers 3138 and 3140 arediametrically opposed to each other on opposite sides of bore 3125 andare located toward the proximal end of bore 3125. Finger 3140 has alarger width than finger 3138.

Annular groove 3142 is located in body rear surface 3108 spaced from andsurrounding the opening of thru bore 3125. Groove 3142 is dimensioned toreceive O-ring 3144 (FIG. 32). The O-ring 3144 is seated in groove 3142.The O-ring 3144 forms a seal between receiver housing 3102 and plate3350. In some versions of the invention an adhesive is used to holdO-ring 3144 in groove 3412. A rectangular shaped chamber 3146 is definedin triangular extension 3105 and has an opening towards front surface3106. Chamber 3146 is dimensioned to receive a printed circuit board aswill be described later.

A terminal assembly 3150 is mounted in receiver housing 3102. Terminalassembly 3150 includes several elongated electrically conductiveterminals 3152 that are electrically separated by an insulator 3154.Terminals 3152 are formed from a conductor material such as a copperalloy. Insulator 3154 is a material such as polyimide that is moldedaround terminals 3152 to form terminal assembly 3150.

In one embodiment, terminal assembly 3150 is placed in the same moldthat is used to injection mold receiver housing 3102 from plastic. Inanother embodiment, terminal assembly 3150 is hermetically sealed toreceiver housing 3102. After molding or sealing, terminal assembly 3150is an integral part of receiver housing 3102. Terminal assembly 3150defines an internal passage 3155 within sleeve 3118 through whichterminals 3152 extend.

In another embodiment, terminal assembly 3150 is a flexible circuit thatis inserted into internal passage 3155 within sleeve 3118. The flexiblecircuit is then held in place using a silicone adhesive or otherappropriate curable adhesive or sealant.

Terminals 3152 further have flush proximal contact ends 3156 that facetowards bore 3125. Terminals 3152 also have distal contact ends 3158that extend perpendicularly away from the sleeve outer surface 3124.Contact ends 3156 and 3158 are electrically connected to otherelectrical components as will be described later. In another embodiment,another set of terminals 3160 may extend through passage 3155 andthrough another passage 3162 defined in extension 3105. Terminals 3160have ends 3164 that terminates in chamber 3146 and ends 3166 thatextends perpendicularly away from sleeve outer surface 3124 and areadjacent to contact ends 3158.

With additional reference to FIG. 31, an optional embodiment may containan electronic sterile barrier monitoring system with Hall Effect printedcircuit board 3170 which has an attached Hall Effect sensor 3172. HallEffect printed circuit board 3170 is mounted in chamber 3146 and iselectrically connected to terminal ends 3164 by suitable methods such assoldering or wire bonding. Hall Effect sensor 3172 detects the presenceor absence of magnet 448 (FIG. 29). When cover 450 is mounted andlatched to container 2902, Hall Effect sensor 3172 detects the magneticfield generated by magnet 448 and transmits an electrical signalindicating a detected magnetic field. When cover 450 is removed fromcontainer 2902, lid latch 496 is pivoted away from Hall Effect sensor3172 causing sensor 3172 to detect the absence of a magnetic field andtransmits an electrical signal indicating no magnetic field.

Turning to FIG. 34, details of retainer ring 3200 and cover 3250 areshown. Retainer ring 3200 is generally round in shape and has a proximalface 3202, a distal face 3204, an outer annular surface 3206 and aninner annular surface 3208. The outer peripheral edge of distal face3204 is beveled. Threads 3210 are defined in inner annular surface 3208.Retainer ring threads 3210 mate with receiver housing threads 3129 inorder to secure and seal sensor module receiver 3100 to container 2902.Threaded bores 3212 extend perpendicularly from distal face 3204partially into retainer ring 3200.

Cover 3250 is generally round in shape with an extended section 3252.Cover 3250 has a distal face 3254, a proximal rim 3255, an outer annularsurface 3256 and an inner step 3258. Inner step 3258 defines innerannular surface 3262. Inner annular surface 3262 terminates at proximalface 3254 and defines an opening 3263. A circular skirt 3260 extends ina proximal direction away from step 3258 and terminates at rim 3255.Skirt 3260 and annular surface 3262 defines thru bore 3264. The outerperipheral edge of distal face 3254 is beveled.

Two diametrically opposed arcuate ribs 3270 extend perpendicularly frominner annular surface 3262 into bore 3264. The inner edges of ribs 3270are beveled. The distal facing surface of ribs 3270 is flush withproximal face 3254. Two holes 3272 are defined in each rib 3270. Holes3272 extend entirely through rib 3270. Ribs 3270 define twodiametrically opposed arcuate gaps 3274 located between each of ribs3270.

Extended section 3252 is formed with a rectangular circuit board holder3280. Holder 3280 includes a distal facing opening 3282 and a bottomwall 3284. Holder 3280 is open at distal face 3254. Apertures 3286 aredefined in bottom wall 3284.

With additional reference to FIG. 31, a container printed circuit board(PCB) 3800 is mounted and retained in holder 3280. Opening 3282 isdimensioned to receive PCB 3800. Specifically, PCB 3800 is fastened tobottom wall 3284 by self tapping screws 3290 threaded into apertures3286. Standoffs 3292 are positioned between bottom wall 3284 and PCB3800 in order to space PCB 3800 from bottom wall 3284. Screws 3290 alsoextend through standoffs 3292. The components of container PCB 3800 willbe described later. A transparent lens 3294 is mounted to distal face3254 covering opening 3282. Lens 3294 allows a user to visually seelight emitting diodes mounted to PCB 3800. Lens 3294 is attached todistal face 3254 using ultrasonic welding or is heat staked.

PCB 3800 is electrically connected to terminal assembly 3150 (FIG. 33).Specifically, PCB 3800 is connected to terminal ends 3158 and 3166 bysuitable methods such as soldering or wire bonding. PCB 3800 is incommunication with optional embodiment containing Hall Effect PCB 3170via terminals 3160 (FIG. 33).

Retainer ring 3200 is attached to receiver housing 3102 by the mating ofretainer ring threads 3210 with receiver housing threads 3129. Next,cover 3250 is mounted to retainer ring 3200. Cover 3250 is aligned withreceiver housing 3102 and moved in the proximal direction so that coverribs 3270 slide or fit into receiver housing gaps 3138 and receiverhousing shoulders 3134 slide or fit into cover gaps 3274.

Cover 3250 contacts retainer ring 3200 such that cover step 3258 abutsring distal face 3204 and cover skirt 3260 surrounds ring outer annularsurface 3206. Fasteners such as screws 3296 extend through rib holes3272 and are retained in threaded bores 3212 thereby attaching cover3250 to retainer ring 3200.

Referring now to FIGS. 31 and 35, sensor module receiver 3100 furtherincludes a carriage assembly 3300. Carriage assembly 3300 is attached toreceiver housing 3102. Carriage assembly 3300 guides the movement ofplate 3350 between the open and closed positions of the plate. Carriageassembly 3300 comprises support bracket 3302, plate 3350 and lockmechanism 3400.

Support bracket 3302 includes a base 3304 with four orthogonal arms 3306extending away from base 3304. Arms 3306 form an X-shape. Each arm 3306has an attached distal foot 3310 that is oriented at an approximate 45degree angle to arm 3306. From the center of each foot 3310, acylindrical shaped post 3312 extends perpendicularly away from foot 3310and has a terminal end 3313. From an outer side of each foot 3310, arectangular shaped leg 3314 extends perpendicularly away from foot 3310and has a terminal end 3315. Posts 3312 are parallel to legs 3314. Ahole 3316 is defined in each leg 3314 towards terminal end 3315. Anaperture 3320 is defined in each of the lower most arms 3306. Supportbracket 3302 surrounds an interior area 3322.

Plate 3350 is generally round in shape and is mounted to support bracket3302 for sliding movement along posts 3312. Plate 3350 has a proximalside 3354, a distal side 3352 and an outer annular surface 3356. Fourears 3358 extend radially away from outer annular surface 3356. Ears3358 are spaced 90 degrees apart from each other on outer annularsurface 3356. A bore 3359 is formed in each ear 3358. Bore 3359 extendsthrough the entire thickness of ear 3358. Bore 3359 is accurately formedto allow sliding movement of plate 3350 along post 3312.

Plate 3350 further has a first annular step 3360 defined in proximalside 3354 and a second annular step 3362 defined in proximal side 3354.Step 3360 has a larger diameter than step 3362 and encircles step 3362.A threaded bore 3364 is defined at the center of step 3362. Bore 3364 isperpendicular to step 3362.

A third annular step 3368 is formed in distal side 3352 and defines anannular channel 3370. The remaining portion of distal side 3352 forms adistally directed annular face 3355. After assembly, annular face 3355is juxtaposed to face seal O-ring 3144 seated in groove 3142. Circularshaped drum 3372 extends in a distal direction perpendicularly away fromthe center of step 3368. A cylindrical boss 3374 extends from drum 3372in a distal direction parallel to drum 3372. Boss 3374 has a smallerdiameter than drum 3372. A pair of diametrically opposed shoes 3376 isattached to boss 3374 by spars 3378. Shoes 3376 are spaced from boss3374 by spars 3378. A slot 3377 is defined between the opposed faces ofshoes 3376. Receptacles 3380 are defined between the proximal facingportion of shoe 3376 and the distal facing portion of boss 3374. Slot3377 and receptacles 3380 are dimensioned to receive a portion of case3502 as will be described later.

Plate 3350 is coupled to posts 3312 such that plate 3350 slides alongposts 3312. A plate return coil spring 3382 is mounted over andsurrounds each post 3312. One end of coil spring 3382 abuts foot 3310and the other end of coil spring 3382 abuts the proximal face of ear3358. Bores 3359 are aligned with posts 3312 and plate 3350 is slid ontoposts 3312 such that posts 3312 extend through bores 3359. In thisposition, plate return coil spring 3382 is compressed between foot 3310and the proximal face of ear 3358. Plate return coil spring 3382 biasesplate 3350 in a distal direction towards receiver housing 3102.

Carriage assembly 3300 also includes a lock mechanism 3400. Lockmechanism 3400 functions to prevent plate 3350 from being opened ormoved to an open position when plate 3350 is in a closed position. Lockmechanism 3400 comprises a hub 3402 with four orthogonal arms 3406extending away from hub 3402. The ends of arms 3406 are rounded. Hub3402 has a distal facing oval shaped raised wall 3408 that surrounds anddefines oval shaped central opening 3410.

A rod 3412 is mounted to a proximal facing surface of each of arms 3406.Rods 3412 extend in a proximal direction perpendicular to and away fromarms 3406. The terminal ends of rods 3412 are rounded. Lever 3414 isconnected to hub 3402. Specifically, lever end 3416 is attached to hub3402. The other lever end 3418 is curved or hooked. Lever 3414 isconfigured to be manually grasped by an operator.

Lock mechanism 3400 is retained to plate 3350 in a manner that allowssliding movement by lock mechanism 3400 relative to plate 3250. Afastener such as threaded screw 3422 extends through opening 3410 and isreceived and retained in plate threaded bore 3364. Screw 3422 has a headthat is dimensioned to have a larger diameter than the width of opening3410. During installation, the head of screw 3422 is drawn against theproximal surface of hub 3402, thereby retaining lock mechanism 3400 toplate 3250.

A lumen 3424 is formed thru the bottom of oval shaped raised wall 3408below opening 3410. A lock return coil spring 3426 is disposed in lumen3424 such that one end of spring 3426 abuts screw 3422 and the other endabuts the outer circumferential wall of step 3362. Return coil spring3426 biases lock mechanism 3400 in an upward direction towards cover 450(FIG. 30).

Carriage assembly 3300 is assembled by sliding plate 3350 with attachedlock mechanism 3400 over posts 3312 with coil springs 3382 such thatposts 3312 extend through bores 3359. The carriage assembly 3300 is thenmounted to receiver housing 3102. Each of the four support bracket legs3314 are positioned in housing receiver slots 3112 such that leg holes3316 are aligned with housing receiver bores 3114. Threaded fasteners3430 extend thru leg holes 3316 and into bores 3114. Carriage assembly3300 is thereby connected to receiver housing 3102.

With specific reference to FIGS. 31 and 36, details of removable sensormodule 3500 are illustrated. Removable sensor module 3500 is insertedinto and received by sensor receiver 3100. Removable sensor module 3500contains one or more sensors for sensing the operating environmentwithin container 2902 (FIG. 29). Removable sensor module 3500 comprisesa circuit board assembly 3700 that is mounted to a sensor case 3502.Sensor case 3502 is generally cylindrical in shape and has a proximalend 3504 and a distal end 3506. Case 3502 has an outer annular surface3508. Case 3502 further includes a central dividing wall 3510 thatbisects case 3502 and is perpendicular to outer surface 3508. A firstannular skirt 3512 extends in a distal direction from wall 3510terminating at distal end 3506. A second annular skirt 3520 extends in aproximal direction from wall 3510 terminating at proximal end 3504.Second skirt 3520 and dividing wall 3510 define an annular cavity 3530.

First skirt 3512 is bisected by a grip 3514 that extends across thediameter of first skirt 3512. The base of grip 3514 is connected to thedistal facing side of dividing wall 3510. Grip 3514 and first skirt 3512define two finger cutouts 3516. An operator manually manipulates orrotates removable sensor module 3500 by inserting their fingers intocutouts 3516 and squeezing grip 3514 between their fingers.

A cylindrical shaped drum 3522 extends perpendicularly from the centerof dividing wall 3510 in a proximal direction. An oval shaped head 3523is attached to drum 3522 by a shaft 3526. Head 3523 is spaced away fromdrum 3522 in the proximal direction by shaft 3526. Head 3523 includes apair of diametrically opposed fins 3524 that extend away from head 3523in opposite directions. Fins 3524 are perpendicular to shaft 3526. Head3524 and fins 3525 are dimensioned to mate with shoes 3376 (FIG. 35). Agap 3525 is defined between fins 3524 and the proximal facing side ofdrum 3522.

Fins 3524 mate with shoes 3376 (FIG. 35) in order to couple case 3502 toplate 3350. Head 3523 is dimensioned to fit into plate slot 3377 (FIG.35) when case 3502 is oriented such that fins 3524 are parallel to shoes3376 (FIG. 35). As case 3502 is manually inserted in a proximaldirection into receiver housing 3102, head 3523 will eventually contactand abut the distal facing side of boss 3374. In this position, case3502 is rotated 90 degrees causing fins 3524 to move into receptacles3380. Receptacles 3380 are dimensioned to receive fins 3524. Case 3502is now retained to plate 3350.

An annular groove 3532 is defined in outer annular surface 3508. Groove3532 is dimensioned to receive a circular O-ring 3534. O-ring 3534 isseated in groove 3532. O-ring 3534 forms a seal with the inner annularsurface 3122 (FIG. 33 of sleeve 3118 (FIG. 33).

Two channels 3540 and 3541 are defined in the case outer annular surface3508. Channels 3540 and 3541 are diametrically opposed to each other onopposite portions of the circumference of case 3502. Channel 3540 has anentrance opening 3542 (FIG. 31) that is adjacent proximal end 3504.Channel 3541 has an entrance opening 3543 (not shown) that is adjacentproximal end 3504. Channel 3541 and entrance opening 3542 are formed tohave a larger or wider width than channel 3540 and entrance opening3542. Channel 3540 angles from opening 3542 in a distal direction alongthe circumference of surface 3508 and terminates in an L-shaped trap3544. Channel 3541 angles from opening 3543 in a distal direction alongthe circumference of surface 3508 and terminates in another L-shapedtrap 3544. Channel 3540 is dimensioned to mate with and receive finger3138 during the loading of sensor case 3502 into receiver housing 3102.Channel 3541 receives and mates with finger 3140 during the loading ofsensor case 3502 into receiver housing 3102. Fingers 3138, 3140 andchannels 3540, 3541 act as a key and keyway respectively to properlyalign and index case 3502 with respect to receiver 3100.

Because opening 3542 is smaller than the width of finger 3140, if case3502 is misaligned with receiver 3100, case 3502 is blocked from beinginserted into receiver 3100. Case 3502 can only be inserted intoreceiver 3100 when finger 3138 is aligned with channel opening 3543 andfinger 3140 is aligned with channel opening 3542.

Case 3502 also includes a connector passage 3550 that is located betweenone of the traps 3544 and proximal end 3504. Connector passage 3550extends perpendicularly through second skirt 3520 into cavity 3530.Connector passage 3550 is dimensioned to receive a connector 3750 thatis attached to circuit board assembly.

Threaded bores 3554 are defined in the proximal face of dividing wall3510 located at the bottom of cavity 3530. Threaded bores 3554 extendperpendicularly into wall 3510 and are dimensioned to receive theexternal threaded distal end 3558 of PCB standoffs 3556. PCB standoffs3556 also have an internal threaded proximal end or head 3560. PCBstandoffs 3556 are screwed into bores 3554 forming a support for circuitboard assembly 3700.

Turning to FIGS. 36, 37A and 37B, details of circuit board assembly 3700are shown. Assembly 3700 has a printed circuit board (PCB) 3701 that isgenerally planar and doughnut shaped. PCB 3701 includes a proximalfacing side 3702 and a distal facing side 3704 a circular opening 3706is defined through the center of PCB 3701. PCB 3701 is mounted in casecavity 3530. Specifically, PCB distal side 3702 rests on and issupported by standoffs 3556 with side 3702 abutting head 3560. Skirt3520 surrounds the outer circumferential edge of PCB 3700. In thisposition, head 3523 (FIG. 36) and drum 3522 (FIG. 36) extend throughcentral opening 3706. Screws 3710 extend through PCB holes 3712 and arereceived by internally threaded heads 3560 retaining PCB 3701 to case3502.

PCB 3701 is a multi-layer printed circuit board that includes numerousprinted circuit lines 3716 for the interconnection of electricalcomponents and sensors mounted on PCB 3701. A battery 3720, processor1020, memory 1022, I/O interface 1124 and wireless transceiver 1138 aremounted to the distal facing side 3704 of PCB 3701. Battery 3720supplies electrical power to the components of circuit board assembly3700. Processor 1020, memory 1022, I/O interface 1124 and wirelesstransceiver 1138 are the same as previously described in FIGS. 12B and13.

One or more sensors are mounted to the removable sensor module 3500 andconnected to PCB 3701. In the embodiment shown, sensors are mounted toproximal facing side 3702 of PCB 3701. Water vapor 1024, pressure sensor1026 and temperature sensor 1028 are mounted to side 3702. Water vaporsensor 1024, pressure sensor 1026 and temperature sensor 1028 are thesame as previously described in FIGS. 12B and 13. In an optionalembodiment, also mounted to side 3702 is an optical sensor 1052 thatsenses the amount of infrared (IR) or ultraviolet (UV) light transmittedthrough an optical path length 3770 within container 2902. In oneembodiment, optical sensor 1052 detects and measures concentrations ofhydrogen peroxide vapor (H₂O₂). In one embodiment, optical sensor 1052detects water vapor or another gas or vapor where absorbancecharacteristics of the gas or vapor are known.

Optical sensor 1052 includes an IR or UV source or emitter 1056, anoptical reflector or mirror 3764 and an IR or UV receiver or detector1058 mounted to side 3702. Light filters (not shown) can be mountedaround source 1056 or detector 1058 to remove any undesired lightwavelengths. Mirror 3764 is positioned to reflect incident light energytowards detector 1058. Mirror 3764 is formed from a material thatreflects emitter energy 1056 back to detector 1058 such as vacuumdeposited aluminum on glass.

Mirror 3764 allows for a longer optical path length 3770 than wouldotherwise be possible without the use of mirror 3764. A longer opticalpath length 3770 improves the accuracy and precision of measurements ofdetected hydrogen peroxide vapor concentrations.

Because hydrogen peroxide vapor absorbs infrared or ultraviolet light atspecific know wavelengths, the amount of light at that frequencytransmitted through a known path length 3770 containing hydrogenperoxide vapor is proportional to the concentration of the hydrogenperoxide vapor. Other vapors or gases with known wavelength absorbancecharacteristics can be detected and measured by appropriately selectedemitter 1056 and detector 1058.

Connector 3740 is mounted to PCB 3701. Specifically connector 3740 hasan insulating body 3742 that contains several terminals 3744. Terminals3744 are attached PCB 3701 by suitable methods such as soldering. Theother end of terminals 3744 are connected to button contacts 3746.Button contacts 3746 face radially outward from body 3742. Buttoncontacts 3746 mate with receiver housing proximal contact ends 3156(FIG. 33) to form an electrical connection between removable sensorcircuit board assembly 3700 and container printed circuit board 3800.When PCB 3701 is mounted in case 3502, connector 3740 is received by anddisposed in connector opening 3550 (FIG. 36). Button contacts 3746extend slightly beyond insulating body 3742 and extend slightly beyondthe adjoining outer annular surface 3708 (FIG. 36). This extension ofbutton contacts 3746 allows them to mate with proximal contact ends 3156when removable sensor module 2500 is properly inserted into sensorreceiver 3100.

FIG. 38 illustrates details of container printed circuit board (PCB)3800. PCB 3800 is mounted in cover circuit board holder 3280 (FIG. 34).PCB 3800 is generally planar and rectangular in shape. PCB 3800 includesa proximal facing side 3802 and a distal facing side 3804. PCB 3800 is amulti-layer printed circuit board that includes numerous printed circuitlines (not shown) for the interconnection of electrical components andin certain embodiments sensors mounted on PCB 3800. Holes 3810 aredefined in PCB 3800. Screws 3290 (FIG. 31) pass through holes 3810 inorder to retain PCB 3800 to cover 3250 (FIG. 31).

A battery 3820, controller 3830, one or more LEDs 3842, 3844 3846 areall mounted to the distal facing side 3804. Battery 3820 supplieselectrical power to the components of PCB 3800. Controller 3830 is amicro-controller that includes an internal memory that stores sets ofinstruction or software. PCB 3800 may also include memory that can storedata such as measurement data from sterilization process, VSPM data,usage data or other workflow process data for example the operator whoprogrammed the sensor module with VSPM data or operator who assembledthe equipment load into container or the time and date of thesterilization process. The PCB 3800 combined with the removable sensorPCB 3700 functions like steam sensor modules 1000, hydrogen peroxidesensor module 1050, combined steam and hydrogen peroxide sensor module,or other sensor modules 200, 460, 560, 660, 760, 850 described herein.PCB 3800 will have some additional electronic components, some redundantwith removable sensor module PCB 3700 so after removable sensor module3500 is removed, PCB 3800 memory may contain information tied to thespecific sterilization process, equipment load, operator information,programming information and other information required to track, recordor monitor business processes, regulation processes or quality controlprocesses for sterilization events. Controller 3830 is in communicationwith optional Hall Effect circuit board 3170 (FIG. 31) via terminal 3162(FIG. 33). When removable sensor module 3500 is coupled to sensor modulereceiver 3100 (FIG. 31), controller 3830 is in communication withprocessor 1020 via I/O interface 1024. Controller 3830 allows for dataand instructions to be sent and received from processor 1020.

Red LED 3842, yellow LED 3844 and green LED 3846 provide visualinformation to a user of container assembly 2900. LEDS 3842, 3844 and3846 are viewed by a user through transparent lens 3294 (FIG. 31). Inone embodiment, red LED 3842 indicates that container 2902 and itscontents have been processed through a sterilization cycle that wasunsuccessful in meeting a pre-determined set of minimum validatedsterilization process measurements such as previously described VSPM1150 (FIG. 19). As such the contents of container 2902 are considered tobe non-sterile.

In another embodiment, yellow LED 3842 indicates that container 2902 andits contents have not been processed through a sterilization cycle. Inan additional embodiment, green LED 3846 indicates that container 2902and its contents have been processed through a sterilization cycle thatwas successful in meeting a pre-determined set of minimum validatedsterilization process measurements such as previously described VSPM1150 (FIG. 19). As a result, the contents of container 2902 areconsidered to be sterile.

XXIV. Insertion and Removal of Removable Sensor Module

FIGS. 39-43 illustrate a sequence of steps in the insertion and removalof removable sensor module 3500 into and from sensor receiver 3100. Withspecific reference to FIGS. 31 and 39, removable sensor module apparatus3000 is shown in an initial or first position where sensor module 3500is separated from receiver 3100. In this position, plate 3350 iscompressed by springs 3382 against face seal O-ring 3144 forming a sealbetween distally directed annular face 3355 (FIG. 35) and O-ring 3144.In some embodiments, this seal and plate form part of a sterile barrierenclosure with container assembly 2900. Also, in the first position,lock mechanism 3400 is in a locked state. In the locked state, lockmechanism 3400 prevents plate 3350 from being opened or moved away fromreceiver housing 3102 maintaining a sealed position. In the lockedposition, lock mechanism 3400 is in an uppermost location where raisedwall 3408 (FIG. 35) abuts the upper side wall of step 3362 (FIG. 35) androds 3412 are positioned adjacent to and in abutting relationship tobracket arms 3306 preventing movement of plate 3350 in the proximaldirection away from receiver housing 3102.

Turning to FIGS. 31 and 40, sensor module 3500 is shown in a secondposition being loaded into receiver 3100. In this position, lid 450 hasbeen removed from container 2902 and removable sensor module 3500 hasbeen manually inserted into opening 3263 (FIG. 34) and bore 3125 (FIG.34) of sleeve 3118 (FIG. 34). In the second position, O-ring 3534 formsa seal with the inner annular surface 3122 (FIG. 33) of sleeve 3118(FIG. 33). As case 3502 is manually inserted in a proximal directioninto receiver housing 3102, head 3523 will eventually contact and abutthe distal facing side of boss 3374 limiting movement in the proximaldirection. Also, in this location, fingers 3138 and 3140 are alignedwith channel openings 3542 (FIG. 31). Plate 3350 is still in a sealedand locked position.

As part of the process of inserting sensor module, the lever 3414 ismanually pressed downwardly. This places locking mechanism 3400 in theunlocked position. This repositioning of the locking mechanism freesplate 3350 to move inwardly. This freeing of the plate 3500 for movementallows the continued insertion of the sensor module 3500 into thecontainer receiver 3100. As the sensor module is inserted in thereceiver, the module pushes against and displaces plate 3350. Thisdisplacement of plate 3350 temporarily breaks the seal between thereceiver housing 3102 and the plate.

In the unlocked position, lock mechanism 3400 is in a lowermost locationwhere raised wall 3408 (FIG. 35) abuts the lower side wall of step 3362(FIG. 35) and lever end 3418 abuts the outer surface of plate 3350. Thisprevents further downward movement of lever 3414. Also, in the unlockedposition, the two upper rods 3412 are positioned below the upper bracketarms 3306 and the two lower rods are in axial alignment with holes 3320(FIG. 35) allowing movement of plate 3350 in the proximal direction awayfrom receiver housing 3102.

Next, the operator rotates case 3502 45°. This rotation results in fins3524 moving into plate receptacles 3380 and adjacent shoes 3376 (FIG.35). Receptacles 3380 are dimensioned to receive fins 3524. Case 3502 isnow retained to plate 3350.

Case 3502 is then rotated an additional 45°. As a result of thisrotation, fingers 3138 and 3140 track along channels 3540. Thus resultsin case 3502 being drawn in the proximal direction towards bracket 3302.Because case 3502 is coupled to plate 3350, the rotation of case 3502also causes a like movement of plate 3350 in a proximal direction awayfrom receiver housing 3102 opening plate 3350. As plate 3350 moves inthe proximal direction, springs 3382 are compressed and rods 3412 alsomove in a proximal direction past bracket arms 3306 and through holes3320 (FIG. 35). Plate 3350 moves away from O-ring 3144 creating apassage 4110 between plate 3350 and sensor circuit board assembly 3700.Passage 4110 allows sensors on circuit board assembly 3700 to be exposedto the operating environment and conditions within container 2902.

As shown in FIG. 41, case 3502 is now in a position where the distal end3506 of case 3502 has moved slightly past distal face 3254 of cover 3250and into bore 3264 (FIG. 34).

With reference to FIGS. 31 and 42, removable sensor module 3500 is shownin a fourth operational position. When the operator manually releasescase 3502, compressed coil springs 3382 cause plate 3350 and case 3502to move in distal direction such that fingers 3138 and 3140 are seatedin trap 3544 (best seen in FIG. 36). Case 3502 is now rotatably lockedto receiver housing 3102. At the same time, distal movement of case 3502causes contact buttons 3746 (FIG. 37B) to be engaged and seated againstterminal ends 3156 (FIG. 33) creating an electrical connection betweensensor PCB 3702 and container PCB 3800 via terminals 3152 (FIG. 34). Thecomponents of sensor PCB 3702 are now in communication with componentsof container PCB 3800

Surgical instruments 180 to be sterilized are manually loaded intocontainer 2902 and cover 450 is placed over container 2902. Locking lidlatch 496 is moved to a locked position retaining cover 450 to container2902. In an optional embodiment, pivoting of lid latch 496 causes magnet448 to be positioned in proximity to Hall Effect sensor 3172 such thatHall Effect sensor 3172 senses the magnetic field generated by magnet448. Container assembly 2900 is now ready to be processed through asterilization process cycle within sterilization chamber 52 (FIG. 1).During the sterilization process cycle, removable sensor module 3500monitors and collects data in regards to the operating environment,conditions and process measurements within container 2902.

After the sterilization process cycle is completed, sensor module 3500is removed from sensor receiver 3100 while maintaining the sterile stateinside of the container assembly 2900. The sensor module is removed bypressing module case 3502 in the proximal direction while simultaneouslyrotating the case counterclockwise. The proximal movement of the case3502 causes fingers 3138 and 3140 to move out of trap 3544. As case 3502is rotated counterclockwise, fingers 3138 and 3140 track along channels3540 causing case 3502 to be drawn in a distal direction away fromreceiver housing 3102. Plate 3350, it is understood is coupled to thecase 3502 for axial movement. Consequently, the longitudinaldisplacement of case 3502 causes a like displacement of the plate 3350.The movement of case 3502 and plate 3350 in the distal direction isassisted by coil springs 3382. The counterclockwise rotation of case3502 also causes the disconnection of contact buttons 3746 fromterminals ends 3156. FIG. 41 sensor module 3500 is shown in thisposition

Eventually, the distally directed annular face 3355 (FIG. 35) of plate3350 contacts O-ring 3144. This establishes a seal between plate 3350and receiver housing 3102. This seal closes passage 4110 (FIG. 42).After the seal is established, lock mechanism 3400 is biased by coilspring 3426 (FIG. 35) to move into the locked state. Coil spring 3426causes lock mechanism 3400 to move to an uppermost location where raisedwall 3408 (FIG. 35) abuts the upper side wall of step 3362 (FIG. 35)limiting upward movement of lock mechanism 3400 and rods 3412 arepositioned adjacent to bracket arms 3306 preventing movement of plate3350 in the proximal direction away from receiver housing 3102.

During this removal of the sensor module, plate 3350 is pulledoutwardly. This results in the plate 3350 being pressed against O-ring3144. This adds to the force springs 3382 apply to the plate so as tohold the plate in sealed and locked position.

As case 3502 is further rotated counterclockwise, fins 3524 will moveout of engagement with shoes 3376 and out of plate receptacles 3380allowing case 3502 to be separated from plate 3350. Continued manualmovement by the operator of case 3502 in the distal direct causesremovable sensor module 3500 to be removed and separated from receiverhousing bore 3125 (FIG. 34) and opening 3263 (FIG. 34). Throughout theremoval of removable sensor module from sensor receiver, the seals 3534and 3144 act together so that at least one seal will always be sealingto adjacent surfaces, preventing air and microorganisms from enteringthe container throughout the removal process. This at least one sealmaintained embodiment temporarily forms part of the sterile barrierenclosure during the removal process. Removable sensor module 3500 isnow available to be reused with other containers 2902 duringsterilization processing.

Sensor module 3000 is constructed so that a sterile seal is maintainedbetween container 2902 and receiver 3100 regardless of the position ofremovable sensor module 3500. When sensor module 3500 is removed fromreceiver 3100, annular face 3355 (FIG. 35) of plate 3350 and face sealO-ring 3144 form a sterile seal preventing contaminants from moving thrureceiver 3100 and into container 2902. When sensor module 3500 isinserted or removed, O-ring 3534 and inner annular surface 3122 (FIG.33) maintain another sterile seal whenever plate 3350 is in a openposition forming another sterile barrier.

When the container is subjected to sterilization, the surfaces of plate3500 and the adjacent receiver as well the exposed surfaces of O ring3534 are exposed to sterilant. Consequently, when these surface abut soas to form a seal upon the removal of the sensor module, there is littlelikelihood that contaminates will be trapped between these surfaces.

Lock mechanism 3400 is designed so that plate 3350 can only be openedafter cover 450 is open or removed. Lock mechanism 3400 has to bemanually actuated from within container 2902 in order to open. Aftercontainer 2902 has been sterilized and after sensor module 3500 has beendetached from receiver 3100, any subsequent attempts to reinsert anotherremovable sensor module 3500 into receiver 3100 will be blocked by lockmechanism 3400 being in the locked state, thereby maintaining sterileconditions within container 2902. Fourth, because removable sensormodule 3500 can be detached from container 2902, Removable sensor module3500 is available to be reused with other additional containers 2902during sterilization processing. If removable sensor module 3500 is arelatively high cost item, the use of a small number of removable sensormodules 3500 with a larger number of containers 2902 results in a morecost efficient solution for the monitoring of process measurementsduring sterilization processing. Also, sensors or electronics that arelocated on the removable sensor module 3500, will not be exposed topotential damage from cleaning, automated washing and rough handlingthat sensors or electronics permanently mounted to containers mayexperience.

In some of this embodiment of the invention, some of the components thatform part of the sensing assembly are mounted to the container.Typically these components are mounted to the receiver. Components thatmay be so affixed to the receiver include the processor, the memory, theindicator lights or the battery. Also, owing some sensors may bepermanently mounted to the container.

XXIV. Docking Station for Use with Removable Sensor Modules

Referring to FIG. 44, another embodiment of a docking station 1300 isshown. Docking station 4400 is used in conjunction with removable sensorapparatus 3000. Docking station 4400 is used during the loading ofsurgical instruments into containers 2902, to calibrate the sensors ofremovable sensor module 3500 and to recharge batteries. Docking station4400 has many features in common with docking station 1300 previouslydescribed with reference to FIG. 16. Docking station 4400 differs fromdocking station 1300 in that calibration chamber 1320 has been modifiedto eliminate door 1326 (FIG. 16) and to add a fixed front panel 4410.Several sensor receivers 3100 are mounted to front panel 4410. While sixsensor receivers 3100 are shown mounted to calibration chamber 1320,more or fewer sensor receivers 3100 can be used.

Removable sensor modules 3500 are attachable and detachable with each ofthe sensor receivers 3100. The sensor receivers 3100 of docking station4400 are connected to and in communication with docking stationcontroller 1402 (FIG. 17). When sensor modules 3500 are inserted intoreceivers 3100, sensor processor 1020 (FIG. 37A) is in communicationwith docking station controller 1402 and docking station processor 1410(FIG. 17).

Docking station 4400 contains steam generator 1430, hydrogen peroxidegenerator 1432, pressure pump 1434, vacuum pump 1436 and heater 1438(FIG. 17) all of which can be used as needed to provide knownconcentrations and values within calibration chamber 1320 during acalibration procedure.

Docking station 4400 is used in conjunction with removable sensorapparatus 3000 in the same manner that docking station 1300 is used withcontainer 402. Docking station 4400 is used to program removable sensormodule 3500 with validated sterilization process measurements (VSPM)1150 prior to sterilization processing as previously described in step2108 of FIG. 21. Docking station 4400 is used to recharge battery 3720(FIG. 37A) in removable sensor module 3500. Docking station 4400 is usedto calibrate the sensors in removable sensor module 3500 in the samemanner as previously described in steps 2704-2714 of FIG. 27. Sensorcalibration software 1460 (FIG. 17) is used by docking station 4400during the calibration of the sensors associated with a respectiveremovable sensor module 3500. Sensor calibration software 1460 at leastpartially controls the operation of steam generator 1430, hydrogenperoxide generator 1432, pressure pump 1434, vacuum pump 1436 and heater1438 during a calibration procedure.

It is noted that docking station 4400 can be used to program andcalibrate a large number of removable sensor modules 3500 at the sametime.

XXV. Operational Method to Determine if Validated Sterilization ProcessMeasurements have been Achieved During a Sterilization Process UsingRemovable Sensor Modules

Referring to FIG. 45, a flowchart of a method 4500 of determining ifvalidated sterilization process measurements within a container havebeen achieved during a sterilization process using removable sensormodules 3500 is shown. Method 4500 illustrates an exemplary method bywhich container assemblies 3000 and removable sensor module 3500presented within the preceding figures perform different aspects of theprocesses that enable one or more embodiments of the disclosure. In thediscussion of FIG. 45, reference will also be made to components fromFIGS. 29-44.

Method 4500 begins at step 4502 where removable sensor modules 3500 areprogrammed with VSPM 1150. Removable sensor modules 3500 are loaded intodocking station 4400 (FIG. 44) for programming. At step 4502, memory1022 (FIG. 37A) is programmed with specific validated sterilizationprocess measurements (VSPM) 1150. Container programming software 1461(FIG. 17) executing on docking station processor 1410 (FIG. 17)identifies the specific VSPM 1150 associated with the containerequipment load, using the data obtained from handheld reader 1240 (FIG.44), and transmits the VSPM 1150 for storage on memory 1022. Thetransmitted VSPM 1150 are specific to the equipment load to besterilized.

Optionally at step 4502, the sensors of removable sensor module 3500 arecalibrated prior to use. Removable sensor module 3500 is calibratedusing docking station 4400.

Removable sensor module 3500 is removed from docking station 4400 andloaded into a sensor receiver 3100 (FIG. 40) attached to container 2902(FIG. 40) at step 4504. Step 4504 includes manual depression of lockmechanism 3400 within container 2902 when the lid is open to allowinsertion of case 3502. Sensor module 3500 processor 1020 (FIG. 37A)establishes communications with container controller 3830 at this time.

At step 4506, the equipment load of surgical instruments 180 (FIG. 2) isprepared for sterilization processing by an operator. At step 4506, thesurgical instruments are placed into tray 160 (FIG. 2) and tray 160 isplaced into container 2902. Cover 450 (FIG. 40) is attached and closedto container 2902.

In an optional step 4508, the surgical instruments 180 and/or tray 160and/or container 2902 are wrapped in a sterile barrier material prior tosterilization processing.

In an additional optional step at block 4510, sterilization verificationsoftware 1152 (FIG. 14) executing on processor 1020 turns on containeryellow LED 3844 (FIG. 38) indicating to a user that the containerassembly has not yet been processed through a sterilization processcycle.

The container 402 is placed into the sterilization chamber 52 (FIG. 1)at step 4512 and the sterilization process cycle within sterilizationchamber 52 is started (block 4514). During the sterilization processcycle, the sterilization chamber is heated, pressurized and a sterilant,such as steam or hydrogen peroxide gas are pumped into the sterilizationchamber. The sterilization process cycle also includes a cool down phaseand drawing a vacuum on the chamber. These sub-steps remove residualcondensed sterilant from the container. The sterilization chamber is setto operate using a set of chamber process parameters (CPP) 66 (FIG. 1).CPP 66 are the set of nominal process parameter settings within thesterilization chamber. The sterilization chamber is set to operate usingCPP 66.

Also, at step 4514, sterilization verification software 1152 executingon processor 1020 monitors and collects real time data from therespective electronic sensors in sensor module 3500 during thesterilization process. The sensors monitor the environmentalcharacteristics within their respective containers. The collected realtime operating data is stored in memory 1022 as data 1156 (FIG. 14). Forexample, sterilization verification software 1152 executing on processor1020 collects water vapor data from water vapor sensor 1024, pressuredata from pressure sensor 1026, temperature data from temperature sensor1028 and hydrogen peroxide concentration data from hydrogen peroxide gassensor 1052. All of the data recorded during the sterilization processis stored as data 1156 in memory 1022.

In step 4516, the processor 1020 compares the observed environmentalmeasurements to the VSPM 1150. At decision step 4520, sterilizationverification software 1152 operating on processor 1020 determines if thereal time measured data 1156 during the performed sterilization processmeets or exceeds the minimum VSPM 1150 values for each operatingparameter to insure sterilization of the container contents. Forexample, if VSPM 1150 has a minimum temperature and time value of 250degrees Fahrenheit for 20 minutes, sterilization verification software1152 compares these values to the recorded time and temperature valuesin data 1156.

In response to the recorded data 1156 values meeting or exceeding theminimum VSPM 1150 values for each sterilization operating measurement,Method 4500 proceeds to step 4526 where sterilization verificationsoftware 1152 executing on processor 1020 indicates that the containercontents have been successfully sterilized by turning on green containerLED 3846. (FIG. 38). In one embodiment additional data related to thesterilization process may be transferred to container memory of PCB 3800for storage, workflow process or quality control practices. For examplein one embodiment, measurement data, VSPM programmed data set,sterilization verification results, sterilization date and VSPMprogramming operator can be stored on container memory on PCB 3800. Thecontainer assembly is removed from the sterilization chamber and theremovable sensor module 3500 is detached from container 2902 at step4528. The contents of container 2902 remain in a sealed sterile stateduring and after sensor module 3500 has been disconnected from container2902. Method 4500 then ends.

In response to the recorded data 1156 values not meeting or exceedingthe minimum VSPM 1150, processor 1020 proceeds to step 4524, Step 4524is identical to previously described step 2126.

The container is removed from the sterilization chamber and theremovable sensor module 3500 is detached from container 2902 at step4528. The contents of container 2902 should be reprocessed prior to use.Method 4500 then terminates.

During storage, controller 3830 (FIG. 38) executes a set of instructionssimilar to sterile monitor software 1158 (FIG. 14) that causescontroller 3830 to monitor the electrical signal received from optionalembodiment with Hall Effect sensor 3172 (FIG. 31) during storage. Ifcover 450 is opened, the electrical signal from Hall Effect sensor 3172changes triggering controller 3830 to turn off green LED 3846 (FIG. 38)and to turn on red LED 3842 (FIG. 38). The illumination of red LED 3842provides a visual indication to an operator that the contents ofcontainer 2902 are no longer considered sterile.

XXVI. Automatic Closing Container with Scissor Lifting and LoweringMechanism

Turning to FIGS. 46 and 47, another automatic closing container assembly4600 is illustrated. Container assembly 4600 uses a scissors mechanism4700 to close a moveable frame 4750. The frame is closed after thesterilization process is executed and residual sterilant withdrawn fromthe container.

Container assembly 4600 comprises a container 4602. Container 4602 ofFIG. 46 is the same the previously described container 402 of FIG. 7Aexcept that opening 414 and lid latches 496 have been omitted fromcontainer 402. For the description of container assembly 4600, container4602 will be referred to using common reference numbers from FIG. 7A.

Container assembly 4600 further includes a rack or tray 4620. Tray 4620can be formed from suitable materials such as stainless steel oraluminum. Tray 4620 comprises a generally planar rectangular shaped base4622 that is perforated with an array of holes 4626. Holes 4626 allowsterilant to circulate below base 4622. Base 4622 has an upper surface4623 and a bottom surface 4624. Four support feet 4628 are mounted tobase 4622 and extend perpendicularly downward from the bottom surface4624. Feet 4628 rest on the upper surface of support skeleton 4710 whentray 4620 is placed into container 4602.

Tray 4620 is used to hold medical/surgical instruments 180 withincontainer 4602 during sterile processing. Tray 4620 includes a pair ofspaced apart handles 4632 that are mounted to opposite ends of base4622. Handles 4632 allow a user to grasp and lift tray 4620.

Tray 4620 is formed with several support members 4638 that extendupwardly from base 4622. Medical/surgical instruments 180 rest on andare supported by support members 4638. Support members 4638 aredimensioned and shaped so that medical/surgical instruments 180 are heldand retained in a preferred orientation for sterile processing. It isimportant for some medical/surgical instruments 180 to be oriented incertain geometric orientations during sterile processing such thatsterilant can readily enter and exit from the surgical instruments.

Cover 4650 is used to cover and enclose container 4602. Cover 4650includes a generally rectangular shaped panel 4652 that is surrounded bya raised peripheral flange 4654. Cover 4650 is formed from materialssuch as stamped aluminum or other suitable materials. Two latches 4658are mounted to opposite sides of cover 4650. Each latch 4658 isdiametrically opposed to the other and is attached to flange 4654. Latch4658 mates with a clip 4758 that extends outwardly from two ends ofmoveable frame 4750. When cover 4650 is moved downwardly into contactwith moveable frame 4750, latch 4658 slightly pivots and engages clip4758 resulting in the retention of cover 4650 to frame 4750. Cover 4650has an elastomeric gasket 456 (see FIG. 7B) that is retained in a groove455 (see FIG. 7B). Gasket 456 mates with peripheral lip 4760 of frame4750 to form a seal between cover 4650 and moveable frame 4750. Otherlatches can be used that secure and seal cover to moveable frame as longas these latches allow the operator to unlatch, remove the cover andaccess contents inside container.

Container assembly 4600 further includes a scissor mechanism 4700.Scissor mechanism 4700 is received by interior cavity 420 of container4602 and rests on bottom panel 407. Scissor mechanism 4700 is used toraise and lower frame 4750 during sterilization processing of containerassembly 4600. Scissor mechanism 4700 comprises a dog bone shapedskeleton 4710 that is linked by a pair of central cross-members 4712.Skeleton 4710 has opposed ends 4738 and 4739. Skeleton 4710 and crossmembers 4712 define three cavities 4713, 4714 and 4715 within skeleton4710. Four openings 4716 are defined in opposite ends of skeleton 4710.Openings 4716 receive locking fingers 4717 that have an attached slottedhead 4718 that faces upwardly from the top surface of skeleton 4710.With skeleton 4710 resting on container bottom panel 407, slotted heads4718 are rotated using a tool such as a screwdriver forcing lockingfingers 4717 into engagement with a retention feature (not shown) on theinside surface of sides walls 405 and 406. The engagement of lockingfingers 4717 with the retention features fixes skeleton 4710 tocontainer 4602 and retains scissor mechanism 4700 to container 4602. Inone embodiment, skeleton is releasably secured to the bottom ofcontainer. In yet another embodiment, skeleton is fastened to bottom ofcontainer. In all embodiments, skeleton is coupled to container in amanner that allows the skeleton and actuator system to create enoughsealing force between the moveable frame and container to preventingress of microorganisms.

Sensor module 1050 is mounted in cavity 4713 and retained to skeleton4710 by retention means 4711. Sensor module 1050 is the same aspreviously described in FIG. 12B except that an actuator driver circuit4708 is incorporated into module 1050.

Rotary actuator 4720 is mounted in cavity 4714. Rotary actuator 4720 isattached to side sections 4721 of skeleton 4710 by a C-shaped clamp4722. A threaded shaft 4723 extends perpendicularly away from one end ofrotary actuator 4720. Rotary actuator 4720 can be rotated in either aclockwise or counterclockwise rotation causing a like a clockwise orcounterclockwise rotation of threaded shaft 4723. Threaded shaft 4723has a proximal end 4724 closest to actuator 4720, a center section 4725and a distal end 4726.

A moveable carriage 4730 is mounted in cavity 4715. Moveable carriage4730 includes a rectangular shaped block 4731 that is positioned incavity 4715. Block 4731 has a threaded center bore 4731 that extendsentirely through block 4731 and is perpendicular to shaft 4723. Threadedshaft 4723 is screwed into threaded bore 4731 and extends out the distalside of block 4731. The distal end 4726 of shaft 4723 is received in abearing 4732 that is mounted in end 4739 of skeleton 4710.

Two diametrically opposed rods 4734 are fixed to and extend away fromtwo ends of block 4731 in a perpendicular manner. Rods 4734 are receivedby diametrically opposed slots 4719 that are defined in sides ofskeleton 4710 toward end 4739. The travel of moveable carriage 4730 ineither direction is limited by the abutment of rods 4734 against theends of slots 4731.

Because rotary actuator 4720 is fixed to skeleton 4710, clockwiserotation of threaded shaft 4723 causes block 4731 to move away fromactuator 4720. The counterclockwise rotation of threaded shaft 4723causes block 4731 to move toward actuator 4720.

Scissor mechanism 4700 further includes four elongated arms 4770. Eacharm 4770 has a proximal end 4771, a center section 4772 and a distal end4773. Apertures 4775 are defined through each respective proximal end4771, center section 4772 and distal end 4773. Each aperture 4775receives a retaining member 4776.

At skeleton end 4738, the lower arms proximal end 4771 retaining member4776 has a pin 4777 that extends into a hole 4778 in skeleton 4710. Pin4777 allows the lower arm proximal ends 4771 to rotate with respect toskeleton 4710.

At frame end 4756, the upper arms proximal end 4771 retaining members4776 are received into holes (not shown) that extend into frame 4750.Retaining members 4776 allow the upper arm proximal ends 4772 to rotatewith respect to frame 4750. In center section 4772, retaining member4776 pivotally attaches the two crossing arms 4770. Retaining member4776 allows the two arms 4470 to rotate with respect to each other.

At skeleton end 4739, the lower arms distal ends 4773 have apertures4775 through which rods 4734 extend. Rods 4734 extend through distalends 4773 and terminate in slots 4719. Apertures 4775 are dimensioned tobe slightly larger than rods 4734 to allow the lower arm distal ends4773 to rotate with respect to skeleton 4710.

At frame end 4757, the upper arm distal ends 4773 retaining members 4776have pins 4777 that are received by slots 4761 that extend into frame4750. Pins 477 extend perpendicularly away from distal arm ends 4773.Slots 4761 are dimensioned to be slightly larger than pins 4777 to allowpins 4777 to slide in slots 4761. Also, apertures 4775 are dimensionedto be slightly larger than pins 4777 to allow the upper arm distal ends4773 to rotate with respect to skeleton frame 4750.

The perimeter of moveable frame 4750 defines a central opening 4752.With additional reference to FIG. 48, a cross-sectional view of moveableframe 4750 is shown. Moveable frame 4750 includes an upwardly extendingwall 4762 that terminates in lip 4760. Two spaced apart walls 4764 and4765 extend downward from frame 4750 defining a channel 4766 therebetween. Channel 4766 receives an elastomeric split lip gasket or seal4777. Gasket or seal 4777 is split into two lips that define a groove4778. When moveable frame 4750 is lowered by scissors mechanism 4700onto container 4602, gasket 4777 receives and engages rim 413 in groove4778 forming a seal between frame 4750 and container 4602.

Container assembly 4600 further includes several sensors to detect theopening and closing of moveable frame 4750 or the insertion and removalof cover 4650. A close position micro-switch or limit switch 4810 ismounted to skeleton end 4739 facing into cavity 4715. An open positionmicro-switch or limit switch 4812 is mounted to cross-member 4712 facinginto cavity 4715. Micro-switches 4810 and 4812 are in communication withelectronic sensor module 1050 via an electrical cable 4814.

When moveable frame 4750 moves to a closed position, one side of block4731 contacts and closes micro-switch 4810. When moveable frame 4750moves to an open position, another side of block 4731 contacts andcloses micro-switch 4812. When moveable frame 4750 is in the openposition, a passage 4830 is created between container 4602 and frame4750. Processor 1020 (FIG. 13) can interpret the signals frommicro-switches 4810 and 4812 to determine the position of moveable frame4750.

A Hall Effect sensor 4820 is mounted to the inner surface of frame wall4762 facing opening 4752. Hall Effect sensor 4820 is in communicationwith electronic sensor module 1050 via an electrical cable 4822. Amagnet 4824 (FIG. 46) is attached to the raised flange 4654 of cover4650 opposite latch 4658.

When cover 4650 is placed over and attached to moveable frame 4750,magnet 4824 is positioned in proximity to Hall Effect sensor 4820. HallEffect sensor 4820 detects the magnetic field generated by magnet 4824and transmits an electrical signal indicating a detected magnetic fieldto processor 1020 (FIG. 13). When cover 4650 is removed from moveableframe 4750, magnet 4824 is positioned away from Hall Effect sensor 4820.Hall Effect sensor 4820 detects the absence of a magnetic field andtransmits an electrical signal indicating no detected magnetic field toprocessor 1020. Processor 1020 uses the electrical signal to determinethe position of cover 4650.

XXVII. Operational Method to Determine if Validated SterilizationProcess Measurements have been Achieved During a Sterilization ProcessUsing an Automatic Closing Container with Scissor Lifting and LoweringMechanism

Referring to FIG. 49, a flowchart of a method 4900 of determining ifvalidated sterilization process measurements within a container havebeen achieved during a sterilization process using automatic closingcontainer assembly 4600 is shown. Method 4900 illustrates an exemplarymethod by which container assembly 4600 and electronic sensor module1050 presented within the preceding figures perform different aspects ofthe processes that enable one or more embodiments of the disclosure. Inthe discussion of FIG. 49, reference will also be made to componentsfrom FIGS. 46-48.

Method 4900 begins at step 4902, where if the moveable frame 4750 is notin the open position, processor 1020 is triggered to move frame 4750 tothe open position. In one embodiment, container assembly 4600 is placedon docking station 1300 (FIG. 16) and communicatively coupled to dockingstation 1300 using connector 1338 (FIG. 16) and cable 1340 (FIG. 16)that are connected to connector 1032 of electronic sensor unit 1050.Docking station processor 1410 (FIG. 17) in communication with containerprocessor 1020, queries container processor 1020 as to the position ofmoveable frame 4750. If the moveable frame 4750 is not in the openposition, processor 1410 transmits a signal triggering processor 1020 tocause rotary actuator 4720 to rotate threaded shaft 4723 in acounterclockwise manner.

The rotation of threaded shaft 4723 in a counterclockwise manner causesa linear movement of block 4731 in a proximal direction toward actuator4720, which in turn causes scissor arms 4770 to move moveable frame 4750upwardly away from the rim 413 of container 4602. In one embodiment, thecontact of the proximal side of block 4731 with open positionmicro-switch 4812 triggers processor 1020 to turn off rotary actuator4720. Frame 4720 is now in an open position where sterilant can entercontainer 4602 through passage 4830 during sterilization processing. Inan alternate embodiment, container assembly is placed in sterilizerchamber with moveable frame in a closed state. In this embodiment asignal from controller 1020 lifts and opens frame during thesterilization process occurring within sterilizer 52.

At step 4904, sensor module 1050 is programmed with validatedsterilization process measurements (VSPM) 1150. Memory 1022 (FIG. 14) isprogrammed with specific validated sterilization process measurements(VSPM) 1150. Container programming software 1461 (FIG. 17) executing ondocking station processor 1410 (FIG. 17) identifies the specific VSPM1150 associated with the container equipment load, optionally using thedata obtained from handheld reader 1240 (FIG. 44), and transmits theVSPM 1150 for storage on container memory 1022. The transmitted VSPM1150 are specific to the equipment load to be sterilized. The connector1338 and cable 1340 are then disconnected from connector 1032.

The equipment load of surgical instruments 180 is prepared forsterilization processing by an operator. At step 4906, the surgicalinstruments 180 are placed into tray 4620 and tray 4620 is placed intocontainer 4602. If no instrument rack is required per the content ID,instruments are placed inside container without a instrument rack. Cover4650 is attached and closed to moveable frame 4750 via the latching oflatch 4658 to clip 4758 (step 4908). Cover 4650 is now sealed tomoveable frame 4750.

The container 4602 is placed into the sterilization chamber 52 (FIG. 1)at step 4910 and the sterilization process cycle within sterilizationchamber 52 is started (block 4912). During the sterilization processcycle, the sterilization chamber runs the nominal sterilization processby introducing a sterilization agent, such as steam or hydrogen peroxidegas into the sterilization chamber. The sterilization agent enters andexits through passage 4830 created when moveable frame is not in theclosed and sealed position. The sterilization process cycle may alsoinclude a cool down phase and drawing a vacuum on the chamber to removeany residual condensed sterilant. In one embodiment, the sterilizationagent is removed from the contents of the container through passage 4830by maintaining the moveable frame in a open position during this phaseof the sterilization process. The sterilization chamber is set tooperate using a set of chamber process parameters (CPP) 66 (FIG. 1). CPP66 are the set of nominal process parameter settings for thesterilization chamber to operate using CPP 66.

Also, at step 4912, sterilization verification software 1152 (FIG. 14)executing on processor 1020 monitors and collects real time data fromthe respective electronic sensors in sensor module 1050 during thesterilization process cycle. The sensors monitor the operating processmeasurements and conditions within their respective container. Thecollected real time operating data is stored in memory 1022 as data 1156(FIG. 14). For example, sterilization verification software 1152executing on processor 1020 collects water vapor data from water vaporsensor 1024, pressure data from pressure sensor 1026, temperature datafrom temperature sensor 1028 and hydrogen peroxide concentration datafrom hydrogen peroxide gas sensor 1052. All of the data recorded duringthe sterilization process is stored as data 1156 in memory 1022.

Sterilization verification software 1152 executing on processor 1020 atstep 4914 compares the observed real time data 1156, collected duringthe sterilization process cycle, to VSPM 1150. At decision step 4916,sterilization verification software 1152 operating on processor 1020determines if the measured data 1156 during the performed sterilizationprocess meets or exceeds the minimum or threshold VSPM 1150 values foreach operating parameter to insure sterilization of the containercontents. For example, if VSPM 1150 has a minimum temperature and timevalue of 250 degrees Fahrenheit for 20 minutes, sterilizationverification software 1152 compares these values to the recorded timeand temperature values in data 1156.

In response to the recorded data 1156 values meeting or exceeding theminimum or threshold VSPM 1150 values for each sterilization operatingparameter indicating sterilization of the container contents, method4900 proceeds to step 4920. At step 4920, processor 1020 triggers rotaryactuator 4720 to rotate threaded shaft 4723 in a clockwise manner. In analternate embodiment after VSPM data have been verified, sterilizationverification software keeps passage 4830 open to affect sterilizationagent removal from the container contents prior to closing passage withmoveable frame. In this embodiment, closing signal can be sent fromcontroller based on a specific time interval following the lethalsterilization part of the cycle or after a certain sensor monitoredsignal indicating sterilization agent removal is complete.

The clockwise rotation of threaded shaft 4723 causes a linear movementof block 4731 in a distal direction toward skeleton end 4739, which inturn causes scissor arms 4770 to move moveable frame 4750 downwardlyinto engagement with rim 413 of container 4602. In one embodiment, thecontact of the distal side of block 4731 with closed positionmicro-switch 4810 triggers processor 1020 to turn off rotary actuator4720.

Moveable frame 4720 is now sealed to container 4602 and is in the closedposition. The lid being in the closed state functions as indication thatthe load in the container is properly sterilized. The contents ofcontainer assembly 4600 are now in a sealed sterile state and are readyfor storage. In this basic execution of method 4900, residual sterilantvents from the container, through microbial barriers into the ambientenvironment.

In response to the recorded data 1156 indicating that the environmentalmeasurements did not meet the VSPM 1150, the processor, as representedby step 4922, holds the frame in the open position. The frame 4750 beingin the open state, serves as an indication that the contents of thecontainer were not properly sterilized.

During storage, processor 1020 executes a set of instructions such assterile monitor software 1158 (FIG. 14) that causes processor 1020 tomonitor the electrical signal received from Hall Effect sensor 4820(FIG. 47) during storage. If cover 4650 is opened, the electrical signalfrom Hall Effect sensor 4820 changes, triggering processor 1020 to movethe moveable frame 4750 to the open position. In an alternateembodiment, sterile monitor software flashes an LED instead of openingthe moveable frame. The moveable frame 4750, in the open position,indicates to a technician that the contents of the container 2602 are nolonger considered to be sterile.

In one alternative version of this embodiment, after the sensor modulemeasures the environmental characteristics in the container after thesterilizing portion of the sterilization process is executed. Thismonitoring occurs after the evaluation of step 4916 indicates that theload in the container is properly sterilized. During this phase ofoperation, the sensors measure the extent to which residual sterilant isstill present in the container. The processor, based on thesemeasurements, determines it the residual sterilant is at or below anacceptable level. When the processor determines that the container is inthis state, the processor then executes step 4920 so as cause the frameto close so as to seal the container.

XXVIII. Operational Method to Verify Sterilization Process Parameters ina Container During a Steam Sterilization Process

Referring to FIG. 50, a flowchart of a method 5000 of determining ifverified sterilization process measurements within a container have beenachieved during a steam sterilization process is shown. Method 5000illustrates an exemplary method by which any of the container assemblies90, 300, 400, 500, 600, 700 and 800 (90-800) and electronic sensormodules 200, 460, 560, 660, 760, 850, 950, 1000, 1050 and 1080(200-1080) presented within the preceding figures perform differentaspects of the processes that enable one or more embodiments of thedisclosure. Method 5000 is described specifically as being performedusing container assembly 400 (FIG. 7A) and sensor module 1050 (FIG.12B). However, method 5000 can be performed using any of containerassemblies 90-800 and electronic sensor modules 200-1080. Thedescription of the method is provided with general reference to thespecific components illustrated within the preceding figures. In thediscussion of FIG. 50, reference will also be made to components fromFIGS. 7A, 12B and 15.

Generally method 5000 is described as being implemented via containerprocessor 1020 and particularly the execution of code provided bysoftware/firmware modules acting within processor 1020. It is howeverappreciated that certain aspects of the described methods may beimplemented via other processing devices and/or execution of other code.

Method 5000 begins at step 5002 where the equipment load of surgicalinstruments 180 is prepared for sterilization processing by an operator.Step 5002 includes the positioning of container 402 onto docking station1200 or 1300 and if the container has a connector, connecting thecorresponding connector 485, 1032 to the docking station. At step 5002,the handheld reader 1240 is used to scan container 402, tray 160 and thesurgical instruments 180 to be sterilized. At step 5006, the surgicalinstruments are placed into tray 160, tray 160 is placed into container402 and the cover 450 is attached and latched closed. During the loadingof surgical instruments, 180, the operator refers to the display screen1260 shown by docking station 1200 or 1300 to view the correct equipmentload and orientation.

In an optional step 5004, the sensors of electronic sensor module 1050are calibrated prior to use. Electronic sensor modules 1050 iscalibrated using docking station 1300.

At step 5008, the memory 1022 within container 402 is programmed withspecific verified steam sterilization process parameters (VSPP) 1150.Container programming software 1461 (FIG. 17) executing on dockingstation processor 1410 (FIG. 17) identifies the specific VSPP 1150associated with the container equipment load, using the data obtainedfrom handheld reader 1240, and transmits the VSPP 1150 via the connector485 for storage on the container memory 1022. The transmitted VSPP 1150are specific to the equipment load within the container to besterilized.

In the steam sterilization example of FIG. 50, the VSPM 1150 include:

-   1. Temperature Range Indicative Of    -   Saturated Steam: 132° C.≤Tsat≤135° C.-   2. Time Period Exposed Saturated Steam: t≥4 minutes-   3. Acceptable Range of Temperature Differences Between Calculated    Temperature of Saturated Steam And Measured Temperature ±1.6° C.-   4. Range of Temperature Differences Between Measured Temperatures At    Spaced Apart Locations In The Container That Indicates The Load Is    Surrounded By Saturated Steam ±1.6° C.

In an additional optional step at block 5010, is the processor 1020turning on a yellow light emitting diode (LED) of LEDS 1030. This is toindicate the container assembly has not cycled through the sterilizationprocess.

In step 5102 the container 402 is placed into the sterilization chamber52. Step 5014 is the starting of the sterilization process. During thesterilization process, the sterilization chamber is heated, pressurizedand a steam sterilant is introduced into the sterilization chamber. Thesterilization process cycle also includes a cool down phase and drawinga vacuum on the chamber to remove any residual condensed sterilant. Thesterilization chamber is set to operate using a set of chamber processparameters (CPP) 66 (FIG. 1). CPP 66 are the set of process parametersettings within the sterilization chamber. The sterilization chamber isset to operate using the CPP 66.

Also, at step 5014, processor 1020 running sterilization verificationsoftware 1152 monitors and collects real time data from the respectiveelectronic sensors with which it is in communication during thesterilization process cycle. The sensors monitor the characteristics ofthe environment in the container in which the sensors are mounted. Thecollected measurements, which are time based are stored in memory 1022as data 1156. For example, processor 1020 collects humidity data fromhumidity sensor 1024, pressure data from pressure sensor 1026,temperature data from temperature sensor 1028 and time data. Thetemperature data includes recording the temperature during the incomingsteam phase (Tsteam), the temperature of the load (Tsurrogate) and thetemperature of the steam laden atmosphere within the air detection lumen(Tair detector). The temperature of the load is referred to as asurrogate temperature because it can be difficult to provide sensorsthat monitor the temperature of the load. Instead, the sensors monitorthe void near the load. The surrogate temperature should thus beconsidered substantially equal to if not identical to the actualtemperature of the load. The temperature of this void is considered asurrogate for the temperature of the load. All of the data recordedduring the sterilization process is stored as data 1156 in memory 1022.

At step 5016, processor 1020 running sterilization verification software1152 compares the observed real time data 1156, collected during thesterilization process cycle, to VSPM 1150 limits.

At decision step 5018, processor 1020 determines if the real timemeasured data 1156 during the performed steam sterilization process arewithin the VSPP 1150 limits for each operating parameter to insuresterilization of the container contents.

If the measured environmental characteristics meet or the VSPM, theprocessor executes step 5024. Step 5024 is identical to previouslydescribed step 2122.

The measured environmental characteristics may not meet the VSPM for theload. If this condition exists, the processor executes step 5022. Step5022 is understood is identical to step 2126.

In response to the sterilization process cycle not being completed atstep 5020, method 5000 returns to step 5016 where processor 1020continues monitoring and recording sterilization process operatingparameters during the sterilization process cycle.

In response to the sterilization process cycle being complete at step5020, processor 1020 indicates that the container contents have notsuccessfully completed sterilization processing and are not sterile byturning on a red LED such as red LED of LEDS 1030 at step 5022. Method5000 then ends.

FIG. 51 illustrates an example graph 5100 of process parametermeasurements taken by sensor module 1050 inside container 402 ofinstruments that were processed using a steam sterilization process.Only the exposure phase measurements are shown in the graph. FIG. 51shows a graph 5100 of temperature and pressure versus time. Themeasurements include Tsteam (Tmeasured) or Tload 5102, Tair detector5106 and pressure 5108. The graph also includes a superimposed graph ofthe calculated temperature for saturated steam (Tsat 5104) based uponthe pressure measurement within the container.

XXIX. Operational Method to Verify Sterilization Process Parameters in aContainer During a Hydrogen Peroxide Sterilization Process

FIG. 52 is a flowchart of a method 5200 for determining validatedsterilization process measurements for a load sterilized using vaporizedhydrogen peroxide sterilization process is shown. Method 5200illustrates an exemplary method by which the container assemblies 400,500, 600, 700 and 800 (400-800) and electronic sensor modules 460, 560,660, 760, 850, 950, 1000, 1050 and 1080 (460-1080) presented within thepreceding figures perform different aspects of the processes that enableone or more embodiments of the disclosure. Method 5200 is describedspecifically as being performed using container assembly 400 (FIG. 7A)and sensor module 1050 (FIG. 12B). However, method 5200 can be performedusing any of container assemblies 400-800 and electronic sensor modules460-1080. The description of the method is provided with generalreference to the specific components illustrated within the precedingfigures. In the discussion of FIG. 52, reference will also be made tocomponents from FIGS. 7A, 12B and 15.

Generally method 5200 is described as being implemented via containerprocessor 1020 and particularly the execution of code provided bysoftware/firmware modules acting within processor 1020. It is howeverappreciated that certain aspects of the described methods may beimplemented via other processing devices and/or execution of other code.

Method 5200 begins at step 5202 where the equipment load of surgicalinstruments 180 is prepared for sterilization processing by an operator.Step 5202 includes the positioning of container 402 onto docking station1200 or 1300 and if the container has a connector, connecting thecorresponding connector 485, 1032 to the docking station. At step 5202,the handheld reader 1240 is used to scan container 402, tray 160 and thesurgical instruments 180 to be sterilized. At step 5206, the surgicalinstruments are placed into tray 160, tray 160 is placed into container402 and the cover 450 is attached and latched closed. During the loadingof surgical instruments, 180, the operator refers to the display screen1260 shown by docking station 1200 or 1300 to view the correct equipmentload and orientation.

In an optional step 5204, the sensors of electronic sensor module 1050are calibrated prior to use. Electronic sensor module 1050 is calibratedusing docking station 1300.

At step 5208, the memory 1022 is loaded with verified hydrogen peroxidesterilization process measurements (VSPM) 1150. Container programmingsoftware 1461 (FIG. 17) executing on docking station processor 1410(FIG. 17) identifies the specific VSPP 1150 associated with thecontainer equipment load, using the data obtained from handheld reader1240, and transmits the VSPP 1150 via the connector 485 for storage onthe container memory 1022. The transmitted VSPP 1150 are specific to theequipment load within the container to be sterilized.

In the hydrogen peroxide sterilization example of FIG. 52, the VSPM 1150include:

-   1. Minimum Pre-Injection Pressure: Ppre-inject≤0.8 Torr-   2. Vapor Compression Pressure: 300 Torr≤PVC≤450 Torr-   3. Vapor Temp Limits: 20° C.≤Tvapor≤50° C.-   4. Time Integrated H2O2 *Concentration (AREA) Limits:    -   H2O2 Vapor AREA≥2500 mg-s/l-   5. H2O Saturation Limits during Exposure:    -   H2O actual/H2O saturation>0.8

In an additional optional step at block 5210, sterilization verificationsoftware 1152 executing on processor 1020 turns on a yellow lightemitting diode (LED) of LEDS 1030 indicating to a user that thecontainer assembly has not yet been processed through a sterilizationprocess cycle.

Next, the container 402 is placed into the sterilization chamber 52(FIG. 1) at step 5212 and the sterilization process cycle withinsterilization chamber 52 is started (block 5214). During thesterilization process cycle, the sterilization chamber is heated,pressurized and a hydrogen peroxide sterilant is pumped into thesterilization chamber. The sterilization process cycle also includes acool down phase and drawing a vacuum on the chamber to remove anyresidual condensed sterilant. The sterilization chamber is set tooperate using a set of chamber process parameters (CPP) 66.

Also, at step 5214, processor 1020 records the time based measurementsof the environmental characteristics received from the sensors.

The recorded temperature measurements are understood to include thetemperature of the hydrogen peroxide vapor (Tvapor). All of the datarecorded during the sterilization process is stored as data 1156 inmemory 1022.

At step 5216, processor 1020 running sterilization verification software1152 compares the measured environmental characteristics to the VSPM1150. An exemplary set of VSPM 1150 for a load that sterilized withvaporized hydrogen peroxide process is:

-   1. Pre-Injection Pressure: Ppre-inject≤0.8 Torr-   2. Vapor Compression Pressure: 300 Torr≤PVC≤450 Torr-   3. Load Temp: 20° C.≤Tvapor≤50° C.-   4. Time Integrated H2O2 *Concentration (AREA):    -   H2O2 Vapor AREA≥2500 mg-s/l-   5. H2O Saturation during Exposure:    -   H2O actual/H2O saturation>0.8

At decision step 5218, processor 1020 determines if the measuredenvironmental characteristics meet or exceed the VSPM 1150 for the load.The third validated measurement above is an area under a time basedcurve of concentration. Part of step 5218 includes integrating theindividual H2O2 concentrations taken over a time period to determine theintegrated value of these measurements.

In response to the measured environmental characteristics meeting theVSPM, processor 1020 executes step 5224 which is identical to previouslydescribed step 2122.

Alternatively in step 5216 it may be determined that the measuredenvironmental characteristics did not meet the VSPM 115 for the load Ifthis condition exists, the processor executes step 5222 which isidentical to previously described step 2128.

FIG. 53 illustrates an example graph 5300 of process parametermeasurements taken by sensor module 1050 inside container 402 ofinstruments that sterilized with hydrogen peroxide. The pressuremeasurements are graphed using a scale that places the pressuremeasurements during the vapor compression phase (which are around 400Torr) off the visible part of the graph. In the graph 5300 oftemperature and pressure (left axis) versus time and hydrogen peroxideand water vapor concentration (right axis) versus time. The measurementsinclude the temperature of the hydrogen peroxide vapor (Tsertilantvapor) 5304, the pressure in the container prior to vapor injection(Pre-injection pressure) 5312, the hydrogen peroxide concentration 5308and the water vapor concentration 5310.

The measurements of a number of the environmental characteristics areshown as being made repeatedly over the time period of the sterilizationprocess. These are the measurements used in step 5216 to determine theintegrated area under the hydrogen peroxide curve. These measurementsare also used to determine the presence of the saturated water vapor.

The environmental measurements of FIG. 53 are the measurements that arecompared to the VSPM 1150. As a result of this comparison, the processordetermines that four of the measured environmental characteristics metthe validated measurements associated with these characteristics.Specifically the vaporized hydrogen peroxide was compressed to apressure of 400 Torr when the validate measurement for this compressionis the range of 300 to 450 Torr. The vapor state hydrogen peroxide wasat measured to fluctuate at a temperatures between 36 and 38° C. whenthe validate measurement for this temperature is the range of 20 to 50°C. The integrated vaporized hydrogen peroxide over time was 2846 mg-s/l.The validated measurement for this characteristic is a value of at least2500 mg-s/l. The fifth measured environmental characteristic is theratio of total water vapor present to water saturation was calculated at1.63. The test sterilization processes for this load showed that theminimal validated measurement for this characteristic is 0.8.

However, the pre-injection pressure measured during the process was 1.5Torr. The VSPM for this load indicated that the maximum level of thispressure is 0.8 Torr. Consequently when evaluating these data, in step5218 the processor determines that not all the required validatedsterilization measurements were met. The processor 1020 thus wouldexecute step 5222 to provide an indication that the load was notsatisfactorily sterilized.

The containers may have other structural features. For example thecontrol buttons may be mounted to the sensor module. Conductors thatextend from the module connect the buttons to the on containerelectrical devices controlled by the buttons.

In some versions of the invention breakable, frangible single use tamperevident devices may be fitted to the containers of this invention. Thestates of these devices provide visual indicia of the unbroken/brokenstate of the seal around the container. These devices may be used inaddition to or a substitute for the electronic devices described abovethat provide indicia of the unbroken/broken seal state.

Sensors other than Hall sensors may be used to detect the open/closedstate of a container lid. These sensors include mechanical switches andmagnetoresistive transducers.

Likewise the sensor containers that measure the concentration of gas area function of the type of sterilizer with which the containers are used.Some sensors thus monitor the concentration of sterilizing gases such asozone or ethylene oxide. If a sterilizing process involves introducingplural gases into a container the container will have one or moresensors capable of monitoring the concentrations of each of the gases. Asingle sensor assembly is all that is required if the sensor assembly isable to measure and output signals representative of the concentrationsof the plural gases employed in the sterilization process.

It should thus be appreciated that the sensors that monitor gasconcentration are not limited to sensors that function by monitoring theabsorption of light at a selected wavelength. Alternative sensors thatoutput signals that vary as a function of the concentration of the gasmeasured by the sensor may be integrated into alternative versions ofthis invention. These include, for example, transducers that change ineither resistance or capacitance as a function of the concentration oftarget gas.

In a version of the invention with a removable sensor module the sensormodule may include components such as switches that are tripped when themodule is correctly installed. The tripping of the switch causes a lightto be illuminated that indicates the unit is correctly installed.

Likewise, the removable sensor modules of this invention can be placedin a calibration chamber without having to first place the sensormodules in containers.

Therefore, it is an object of the appended claims to cover all suchvariations and modifications that come within the true spirit and scopeof this invention.

What is claimed is:
 1. A method for obtaining validated sterilizationprocess measurements for the sterilization of a surgical instrument,said method including the steps of: placing at least one surgicalinstrument in a sterile barrier; removably inserting said sterilebarrier in an interior chamber of a sterilizer; performing a teststerilization process on the surgical instrument wherein in saidsterilization process, the environment in the sterile barrier ismodified to attempt to sterilize the at least one surgical instrument;while modifying the environment in the sterile barrier, with a sensormeasuring at least one characteristic of the environment in the sterilebarrier and recording the at least one environmental characteristic;after said test sterilization process of the at least one surgicalinstrument, evaluating the at least one surgical instrument to determineif the at least one surgical instrument was sterilized; if, as a resultof said step of evaluating the at least one surgical instrument, it isdetermined that the at least one surgical instrument was not sterilized:executing a subsequent test sterilization process wherein, in thesubsequent test sterilization process, the sterilization process ismodified from the previous test sterilization process; during thesubsequent test sterilization process performing said step of measuringthe at least one characteristic of the environment in the sterilebarrier; and after said subsequent test sterilization process,performing said step of evaluating the at least one surgical instrumentto determine if the at least one surgical instrument was sterilized; andif, as a result of said step of evaluating the at least one surgicalinstrument it is determined that the at least one surgical instrumentwas sterilized, recording the measured at least one characteristic ofthe environment in the sterile barrier as a validated sterilizationprocess measurement for the at least one surgical instrument.
 2. Themethod of claim 1, wherein: said step of measuring the at least onecharacteristic of the environment in the sterile barrier includesrecording the time period for which the at least one environmentalcharacteristic was measured; and in said step of recording the at leastone environmental characteristic for a validated sterilization processmeasurement, the characteristic recorded as the validated sterilizationprocess measurement includes the period of time for which theenvironmental characteristic was measured.
 3. The method of claim 1,wherein: said step of performing a test sterilization process includesat least one of: heating the sterile barrier; introducing steam into thesterile barrier; pressurizing the atmosphere in the sterile barrier; orintroducing a sterilant into the sterile barrier that includes acomponent other than water; said step of measuring an environmentalcharacteristic in the sterile barrier during the test sterilizationprocess includes at least one of: measuring the temperature in thesterile barrier; measuring the pressure in the sterile barrier; ormeasuring the concentration of a gas in the sterile barrier; and saidstep of recording the at least one environmental characteristic as thevalidated sterilization process measurement for the at least onesurgical instrument includes recording at least one of: the temperaturein the sterile barrier; the pressure in the sterile barrier; or theconcentration of a gas in the sterile barrier.
 4. The method of claim 1,wherein said step of executing a subsequent test sterilization comprisesmodifying the subsequent test sterilization process from the previoustest sterilization process by placing the at least one surgicalinstrument in a second sterile barrier that is different from the firststerile barrier prior to modifying the environment in the sterilebarrier.
 5. The method of claim 1, wherein: in said step of placing theat least one surgical instrument in the sterile barrier, a first set ofsurgical instruments is placed in the sterile barrier; and in said stepof executing a subsequent test sterilization process, the subsequenttest sterilization process is modified from the previous teststerilization process by placing a second set of surgical instruments inthe container prior to modifying the environment in the sterile barrier,the second set of surgical instruments being different from the firstset of surgical instruments.
 6. The method of claim 1, wherein said stepof placing the at least one surgical instrument in the sterile barriercomprises placing the at least one surgical instrument in a rigidcontainer.
 7. The method of claim 1, wherein said step of placing the atleast one surgical instrument in the sterile barrier comprises placingthe at least one surgical instrument in a container that consists of aflexible microbial filter that is disposed around the at least onesurgical instrument.
 8. The method of claim 1, wherein said step ofmeasuring and recording the at least one characteristic of theenvironment in the sterile barrier is performed by an assembly disposedin the sterile barrier that is battery powered.
 9. The method of claim1, wherein said step of placing the at least one surgical instrument ina sterile barrier comprises placing the at least one surgical instrumentin a container that includes an anti-microbial filter.
 10. A method ofsterilizing a surgical instrument said method including the steps of:placing at least one surgical instrument in a sterile barrier; removablyinserting said sterile barrier in an interior chamber of a sterilizer;subjecting the sterile barrier to an instrument sterilization process inwhich the environment in the sterile barrier is modified; with at leastone sensor measuring the at least one characteristic of the environmentin the sterile barrier; from a plurality of different validatedsterilization process measurements for a plurality of different surgicalinstruments, selecting a specific sterilization process measurement, thespecific sterilization process measurement being specific to the atleast one surgical instrument that was placed in the sterile barrier;comparing the measured at least one characteristic of the environment inthe sterile barrier to the selected validated sterilization processmeasurement; and based on said comparison step, presenting an indicationregarding whether or not the surgical instrument was sterilized.
 11. Themethod of claim 10, wherein said step of placing the at least onesurgical instrument in the sterile barrier comprises placing the atleast one surgical instrument in a rigid container.
 12. The method ofclaim 10, wherein said step of placing the at least one surgicalinstrument in the sterile barrier comprises placing the at least onesurgical instrument in a container that consists of a flexible microbialfilter that is disposed around the at least one surgical instrument. 13.A sterilization device for a surgical instrument, said sterilizationdevice including: a sterile barrier for holding at least one surgicalinstrument, the sterile barrier adapted for removable insertion in aninterior chamber of a sterilizer, the sterile barrier formed to allowsterilant to enter and residual sterilant to exit so that the surgicalinstrument in the sterile barrier can be subjected to a sterilizationprocess, the sterile barrier further formed to define an anti-microbialbarrier around the surgical instrument; at least one sensor mounted tosaid sterile barrier for measuring at least one characteristic of theenvironment in the sterile barrier; and a processor is attached to thesterile barrier and connected to the at least one sensor to receive fromthe sensor the measurement of the at least one characteristic of theenvironment in the sterile barrier, said processor configured to:compare the measurement of the at least one characteristic of theenvironment in the sterile barrier to a previously recorded validatedsterilization process measurement for the at least one instrument in thesterile barrier; and if the comparison indicates that the measured atleast one environmental characteristic meets or exceeds the validatedsterilization process measurement, causing a display to indicate thatthe at least one surgical instrument in the sterile barrier is sterile.14. The sterilization device of claim 13, wherein: said sensor andprocessor are collectively configured to determine a time period forwhich the at least one environmental characteristic in the sterilebarrier was measured; and said processor is further configured to, whencomparing the measurement of the at least one characteristic of theenvironment in the sterile barrier to a previously recorded validatedsterilization process measurement, makes a comparison to determinewhether or not the at least one environmental characteristic wasmeasured for a previously recorded validated time period.
 15. Thesterilization device of claim 13, wherein the at least one environmentalcharacteristic in the sterile barrier measured by the sensor is at leastone of: temperature in the sterile barrier; pressure in the sterilebarrier; concentration of water vapor in the sterile barrier; or theconcentration of a gas other than water vapor in the sterile barrier.16. The sterilization device of claim 13, wherein the display thatprovides the indication that the surgical instrument was properlysterilized is mounted to the sterile barrier.
 17. The sterilizationdevice of claim 13, wherein a battery is mounted to said sterile barrierand said battery is at least connected to said processor for providingan energization signal to said processor.
 18. The sterilization deviceof claim 13, wherein said processor is further configured so that, ifthe comparison indicates that the measured at least one environmentalcharacteristic does not meet the validated sterilization processmeasurement, said processor causes the display to indicate that the atleast one surgical instrument in the sterile barrier is not sterile. 19.The sterilization device of claim 13, wherein the sterile barriercomprises a rigid container.
 20. The sterilization device of claim 13,wherein the sterile barrier comprises a container that consists of aflexible microbial filter that is disposed around the at least onesurgical instrument.